[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-impairment":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,71,97,120,142,174,199,223,248,269],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100635954","phase-1-a-study-to-assess-the-safety-and-pharmacokinetics-of-incb123667-when-administered-orally-to-adult-participants-with-severe-renal-impairment-or-end-stage-renal-disease-100635954",false,"NCT07559396","A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease","Inclusion Criteria:\n\n* Aged 18 to 85 years, inclusive, at the time of signing the ICF.\n* Severe renal impairment or ESRD based on CKD-EPI.\n* Body mass index of 18.0 to 43.0 kg\u002Fm2 (inclusive).\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.\n* Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.\n* Tobacco or nicotine-containing product use of \\> 10 cigarettes per day within 1 month before screening.\n* Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.\n* Participants who have a history of paracentesis within 3 months prior to check-in.\n* Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.\n* Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.\n* Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria may apply.","ALL","18 Years","85 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.",[27],"Renal Impairment",[29,30,31],"severe renal impairment","Kidney failure","end-stage renal disease","RECRUITING","2026-06-12",{"date":35,"type":36},"2026-06-16","ACTUAL",{"date":38,"type":36},"2026-05-29",{"date":40,"type":21},"2027-01-04",{"name":42,"class":43},"Incyte Corporation","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100619716","phase-1-a-clinical-trial-of-mk-2828-in-people-with-kidney-disease-mk-2828-006-100619716","NCT07348237","A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)","An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-2828 in Participants With Renal Impairment","The main inclusion criteria include but are not limited to the following:\n\n* Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor.\n\nSevere Renal Impairment Participants:\n\n* Has an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin), but is not on hemodialysis (HD)\n\nESRD on HD Participants:\n\n* Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for \\> 3 months prior to study entry\n\nThe main exclusion criteria include but are not limited to the following:\n\nRenal Impairment Participants:\n\n* History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.\n\nHealthy Matched Control Participants:\n\n* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.",true,"24 Years",{"count":55,"type":21},24,[24],"The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.",[59,60,27],"Chronic Kidney Failure","End-Stage Renal Disease","2026-06-01",{"date":63,"type":36},"2026-06-02",{"date":65,"type":36},"2026-03-02",{"date":67,"type":21},"2026-07-20",{"name":69,"class":43},"Merck Sharp & Dohme LLC",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100617187","phase-1-a-study-to-learn-how-the-body-processes-the-study-medicine-pf-07328948-in-people-with-reduced-kidney-function-100617187","NCT07315360","A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function","A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION","Inclusion Criteria:\n\n* Male or female of nonchildbearing potential, between the ages of 18 and 80 years, at the screening visit.\n* BMI of 17.5 to 40.0 kg\u002Fm2 (inclusive), and a total body weight ≥45 kg (99 lbs).\n* Stable renal function, defined as ≤25% difference between 2 measurements of eGFR.\n* Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.\n* Group 1 only: normal renal function (mean eGFR ≥90 mL\u002Fmin) based on an average of measures from the screening visits.\n* Groups 2 \\& 3 only: good general health considered acceptable with the expected health status of individuals with chronic renal impairment.\n* Groups 2 \\& 3 only: chronic renal impairment, defined by the following mean eGFR criteria (based on screening visits):\n\n  * Severe RI: 15 ≤ mean eGFR \\\u003C30 mL\u002Fmin, not requiring hemodialysis.\n  * Moderate RI: 30 ≤ mean eGFR \\\u003C60 mL\u002Fmin.\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption.\n* At screening, a positive result for HIV antibodies.\n* History of renal, liver, or heart transplantation.\n* Urinary incontinence without catheterization.\n* Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.\n* Use of an investigational product within 30 days or 5 half-lives (whichever longer).\n* A positive urine drug test or breath alcohol test at screening or admission to study clinic.\n* Group 1 only: evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.\n* Group 1 only: screening ECG demonstrating QTcF interval \\>450 ms or a QRS interval \\>120 ms.\n* Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg\n* Group 2 \\& 3 only: presence of acute renal disease\n* Group 2 \\& 3 only: requiring dialysis or anticipated need for dialysis\n* Group 2 \\& 3 only: listed for solid organ transplantation\n* Groups 2 \\& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.\n* Groups 2 \\& 3 only: screening ECG demonstrating a QTcF interval \\>470 ms or a QRS interval \\>120 ms.\n* Groups 2 \\& 3 only: unstable medical conditions or comorbidities that would interfere with study participation","80 Years",{"count":80,"type":21},28,[24],"The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function.\n\nThe study will include participants who:\n\n* Are aged 18 to 80 years.\n* Either have normal kidney function or long-term reduced kidney function (moderate or severe).\n* Have a BMI (body mass index) of 17.5 to 40 kilogram per meter squared, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.\n\nAll participants will receive a single dose of PF-07328948 as a tablet taken by mouth. Participants will stay at a clinical research unit for about 6 days to receive the study medicine and undergo safety checks. Total participation lasts up to 64 days, including screening, inpatient stay, and a follow-up call.\n\nThe study is not randomized or blinded, meaning all participants and study staff know which treatment is being given. Group assignment is based on kidney function tests done during screening. The results will help researchers understand how reduced kidney function affects the way PF-07328948 works in the body.",[27,84],"Healthy",[86,27],"Healthy Volunteers","2026-05-11",{"date":89,"type":36},"2026-05-12",{"date":91,"type":36},"2026-01-28",{"date":93,"type":21},"2027-03-13",{"name":95,"class":43},"Pfizer",4,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100635352","phase-1-pharmacokinetics-of-vc005-tablets-in-subjects-with-renal-impairment-and-normal-renal-function-100635352","NCT07551570","Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;\n2. Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;\n3. Male and female participants aged 18 to 70 years (inclusive);\n4. Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive).\n\nExclusion Criteria:\n\n1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;\n2. History of drug abuse, drug addiction and\u002For alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;\n3. Blood donation or significant blood loss (\\> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial;\n4. Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;\n5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;\n6. Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline;\n7. History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of liver disease (regardless of cure), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).","70 Years",{"count":105,"type":21},32,[24],"This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.",[27],"NOT_YET_RECRUITING","2026-04-20",{"date":112,"type":36},"2026-04-27",{"date":114,"type":21},"2026-04-30",{"date":116,"type":21},"2026-10-30",{"name":118,"class":43},"Jiangsu vcare pharmaceutical technology co., LTD",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":44},"100586126","phase-1-study-of-bemnifosbuvirruzasvir-as-a-fixed-dose-combination-in-subjects-with-normal-or-severely-impaired-renal-or-hepatic-function-100586126","NCT06911320","Study of Bemnifosbuvir\u002FRuzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function","A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants","Inclusion Criteria:\n\n* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug\n* Females must have a negative pregnancy test at Screening and prior to dosing\n* BMI of 18.5 to 43.0 kg\u002Fm2\n* Willing to comply with the study requirements and to provide written informed consent\n\nRenal Impaired Subjects (Group 1):\n\n* Considered stable in the judgement of an Investigator\n* Presence of severe renal impairment or kidney failure (as defined by eGFR\\\u003C 30 mL\u002F min)\n\nHepatic Impaired Subjects (Group 2):\n\n* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator\n* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).\n\nSubjects with Normal Hepatic and Renal Function (Group 3):\n\n* Medically healthy, in the opinion of an Investigator\n* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B virus, hepatitis C virus or HIV\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 28 days of dosing\n* Other clinically significant medical conditions or laboratory abnormalities\n\nRenal and Hepatic Impaired Subjects (Group 1 and 2):\n\n* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \\> 10%\n* Undergoing any method of dialysis\n* Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan\n\nRenal Impaired Subjects (Group 1):\n\n* History of renal transplant\n* Concurrent use of medications known to affect the elimination of serum creatinine\n\nHepatic Impaired Subjects (Group 2):\n\n* History of liver transplant\n* Evidence of hepatic carcinoma presence at Screening",{"count":80,"type":21},[24],"To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir\u002FRuzasvir After a Single Dose",[131,132,27],"Healthy Volunteer Study","Hepatic Impairment","2026-04-08",{"date":135,"type":36},"2026-04-13",{"date":137,"type":36},"2025-04-09",{"date":139,"type":21},"2026-05",{"name":141,"class":43},"Atea Pharmaceuticals, Inc.",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":149,"maxAge":18,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100594322","groundbreaking-renal-assist-device-intervening-to-enhance-cardiothoracic-surgery-outcomes-100594322","NCT07017933","Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes","GRADIENT","Inclusion Criteria:\n\nTo be eligible for participation in this study, an individual must meet all the following criteria:\n\n1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and\u002For valvular surgery\n2. Male or Female age 22 to 85 years\n3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL\u002Fmin\u002F1.73m2\n4. Signed and dated informed consent\n5. Female patients of childbearing potential must:\n\n   1. have negative pregnancy test at the informed consent visit,\n   2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \\*The only recommended contraception is condoms.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent\n2. Pregnancy or lactation\n3. Prior cardiac surgery within the last 6 months\n4. Hemodynamic instability as determined by the Principal Investigator\n5. Immunosuppression\n6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)\n7. History of polycystic kidney disease\n8. Patients with only one active kidney or one poorly functioning kidney\n9. Evidence of current kidney obstruction (e.g., Kidney stones)\n10. Evidence of current hydronephrosis\n11. Active upper and\u002For lower urinary tract infections\n12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment\n13. Ongoing sepsis or endocarditis\n14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator\n15. Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and\u002For external genitals; or severe BPH\n16. Unexplained\u002Funexpected gross hematuria as determined by the Investigator\n17. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial\n18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator\n19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures","22 Years",{"count":151,"type":21},124,[153],"NA","Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and\u002For a certain magnitude decrease in estimated glomerular filtration rate (eGFR).\n\nThe JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.",[156,27,157],"Renal Impairment After Cardiac Surgery","Acute Kidney Injury",[159,160,161,162,163],"renal assist device","RAD","renal impairment","acute kidney disease","JuxtaFlow","2026-03-17",{"date":166,"type":36},"2026-03-19",{"date":168,"type":36},"2025-07-16",{"date":170,"type":21},"2027-06-14",{"name":172,"class":43},"3ive Labs",7,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":44},"100625726","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-renal-impairment-and-in-participants-with-normal-renal-function-100625726","NCT07426380","A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function","A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function","Inclusion Criteria:\n\n* Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg\u002Fm²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Group 1\n\n* Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL\u002Fmin)\n* Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening\n\nAdditional Inclusion Criteria for Groups 2 and 3\n\n* Have stable severe renal impairment, assessed by eGFR less than 30 mL\u002Fmin at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing\n* Have acceptable blood pressure and pulse rate\n* If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening\n\nExclusion Criteria:\n\n* Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments\n* Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered\n* Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data\n\nGroups 2 and 3\n\n* Are receiving continuous HD or peritoneal dialysis.\n* Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration",{"count":80,"type":21},[24],"The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).\n\nFor each participant, the study will last about 14 weeks, excluding screening.",[185,186,187,27,188,189],"Kidney Disease","Renal Insufficiency Chronic","Kidney Failure, Chronic","Renal Insufficiency","End Stage Kidney Disease","2026-03-12",{"date":192,"type":36},"2026-03-13",{"date":194,"type":36},"2026-02-24",{"date":196,"type":21},"2026-10",{"name":198,"class":43},"Eli Lilly and Company",{"id":200,"slug":4,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":96},"100609692","NCT07217886","A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls","A Phase 1, Multicenter, Nonrandomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of S-892216-PO in Participants With Varying Degrees of Renal Impairment and Matched Control Participants With Normal Renal Function","Key Inclusion Criteria:\n\n* Considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram during the screening period and on Day -1.\n* Participants With Severe, Moderate, and Mild Renal Impairment not on HD (Group A, D and E): Participants that are not undergoing HD and have mild, moderate, or severe renal impairment based upon the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (estimated glomerular filtration rate \\[eGFR\\]) and the participant's body surface area (BSA) calculated at the screening visit.\n* Participants With Renal Impairment Requiring HD (Group B): Receiving stable HD at least 3 times a week for at least 6 months prior to screening\n* Participants With Normal Renal Function: Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by the 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 milliliters\u002Fminute).\n\nKey Exclusion Criteria:\n\n* Participants with life expectancy less than or equal to 3 months.\n* History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data based on the judgment of the investigator.\n* Participants With Normal Renal Function: History or presence of renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.\n* Participants With Any Renal Impairment (Groups A, B, D, and E): Participant with clinically significant laboratory values in the opinion of the investigator or outside protocol-specified ranges or limits during the screening period or on Day -1.\n* Participants With Severe, Moderate, Mild Renal Impairment not on HD (Groups A, D, and E): Current or anticipated need for HD during the study.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":206,"type":21},40,[24],"The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.",[27],[211,212,213],"S-892216","Hemodialysis","Pharmacokinetics","2025-10-28",{"date":216,"type":36},"2025-10-30",{"date":218,"type":36},"2025-10-16",{"date":220,"type":21},"2026-06-05",{"name":222,"class":43},"Shionogi",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100602507","desir-evaluation-of-the-pre-therapeutic-activity-of-dihydropyrimidine-deshydrogenase-dpd-in-patients-with-cancer-andor-renal-failure-100602507","NCT07124403","DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","DESIR","Inclusion Criteria:\n\n* Signed written informed consent\n* Affiliation to the Social Security System\n* Patients with breast or digestive cancer for whom a fluoroptmidine therapy is being considered\n* OR Patients on dialysis (GFR \\\u003C 10 ml\u002Fmin\u002F1.73 m²)\n* OR Nephrology patients with IR\n\nExclusion Criteria:\n\n* Patient with anemia \\\u003C 8.5 g\u002Fdl\n* Patient with LDH \\> 2 x \\> ULN\n* Legal incapacity or limited legal capacity\n* Subject without health insurance\n* Subject in the exclusion period of another study or in the \"national volunteer file\"",{"count":232,"type":21},742,"OBSERVATIONAL","Fluoropyrimidine drugs (5-Fluorouracil or 5-FU and its prodrug capecitabine) are a widely used in the treatment of numerous solid tumors in adults. Approximately 85% of administered 5-FU is rapidly catabolized in the liver into inactive dihydrofluorouracil (5-FUH2) by dihydro-pyrimidine dehydrogenase (DPD), leaving only a small fraction of the initial drug for an eventual transformation into cytotoxic metabolites. Impeded DPD activity is associated to an increase of cytotoxic metabolites leading to potentially very severe toxicities.\n\nTo prevent these toxicities, a pre-therapeutic measurement of plasma uracil can help assess DPD activity. Indeed, uracil is an endogenous substrate of DPD and an increase in its plasma concentration may be associated with a decrease in DPD activity. In this case, a reduction of the fluoropyrimidine dose is suggested.\n\nHowever, the investigators observed that uracilemia increased concomitantly to the severity of renal impairment. There are two possible explanations for this observation. Either the renal impairment reduces the renal elimination of uracil from blood, or DPD activity is actually impaired. In both cases, this can explain an increase in plasma uracil concentration.\n\nHowever, the impact on fluoropyrimidine dosage is different in the two cases. If the increase in uracilemia is due to renal impairment, DPD activity remains unaffected and there is no need to reduce the fluoropyrimidine dose. If DPD activity is actually impaired, a reduction in the fluoropyrimidine dose is required. In cases of renal impairment, uracilemia may therefore not be as relevant for DPD assessment as in the absence of renal impairment.\n\nTo assess if DPD activity is actually impede during renal impairment, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will be assessed together with uracilemia in patients with or without renal impairment. As uracilemia decreases after dialysis, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will also be assessed in patient before and after dialysis. Four groups of 50 patients will be studied: patients with normal renal function with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL) ; and patients with renal impairment with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL).\n\nThe main objective of the study is to describe the distribution of DPD activity in these four populations. The secondary objectives are to determine in normorenal patients the optimal threshold for DPD activity in non-deficient patients, allowing differentiation between deficient and non-deficient patients based on uracilemia ; and to describe in patients with impaired renal function the distribution of uracilemia with respect to the threshold previously described with the aim of verifying the relevance of uracilemia as a marker of DPD activity in such patients.",[27,236,237],"Digestive Cancers","Breast Cancer","2025-09-11",{"date":240,"type":36},"2025-09-17",{"date":242,"type":21},"2025-09",{"date":244,"type":21},"2028-09",{"name":246,"class":247},"Centre Hospitalier Universitaire de Besancon","OTHER",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":173},"100570536","phase-1-pharmacokinetics-and-safety-of-rupatadine-in-participants-with-renal-impairment-compared-to-control-participants-100570536","NCT06708520","Pharmacokinetics and Safety of Rupatadine in Participants With Renal Impairment Compared to Control Participants","A Study to Investigate Pharmacokinetics and Safety of Rupatadine (10 mg) and Its Active Metabolites in Participants With Renal Impairment Compared to Matched Control Participants With Normal Renal Function","Inclusion Criteria:\n\nParticipants with normal renal function and participants with mild, moderate, or severe renal impairment who meet the following criteria will be considered eligible to participate in the clinical study:\n\n1. Participant understands the study procedures and agrees to participate in the study by giving written informed consent prior to any study-mandated procedure.\n2. Able to communicate well with the Investigator, to understand and comply with the study requirements.\n3. Willing to comply with study restrictions stated in Section 5.3 (lifestyle considerations).\n4. Male or female Caucasian subjects, between 18 and 75 years (inclusive) of age.\n5. Body mass index (BMI) is between 18 to 35 kg\u002Fm2 at Screening.\n6. Women of childbearing potential (WoCBP) must have a negative serum pregnancy test at Screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use (from 30 days prior to dosing, during the entire study, and for at least 30 days after dosing), a highly effective method of contraception (i.e., failure rate of \\\u003C 1%) (Section 10.4 \\[Appendix 4\\]). Such methods include:\n\n   \\- Hormonal contraceptives: combined (estrogen- and progesterone-containing) contraception associated with inhibition of ovulation using oral, intravaginal, or transdermal route of administration.\n\n   Note: If a hormonal contraceptive is used, it must be initiated at least 30 days before dosing.\n   * Intrauterine device.\n   * Intrauterine hormone-releasing system.\n   * Bilateral tubal occlusion.\n   * Vasectomized partner, provided that the partner is the sole sexual partner and that the vasectomized partner has received medical assessment of the surgical success.\n   * Sexual abstinence, defined as refraining from heterosexual intercourse from 30 days prior to dosing up to at least 30 days after dosing, if this is the preferred and usual lifestyle of the subject.\n\n   WoCBP must also agree not to donate ova from the time of informed consent until 30 days after dosing\n7. Women of non-childbearing potential (WoNCBP), i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicular stimulating hormone \\[FSH\\] test), with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, uterine agenesis (Section 10.4 \\[Appendix 4\\]).\n8. Male participants are infertile, vasectomized (who has received medical assessment of the surgical success) or must agree to abstain from, or to use a condom, during heterosexual intercourse with a woman of childbearing potential (Section 10.4 \\[Appendix 4\\]).\n9. Male participants must agree not to donate sperm, from the time of informed consent until 30 days after dosing.\n10. Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-Hepatitis Cvirus antibodies (anti-HCVAb).\n11. Participant agrees to refrain from consuming grapefruit juice, grapefruits, and grapefruitcontaining products from at least 7 days before the dose administration, and until the EOS Visit.\n12. Able to tolerate venipuncture\n\n    For participants with mild, moderate, or severe renal impairment, the following criteria must be met in addition:\n13. Participants with impaired renal function should be hemodynamically stable.\n14. Diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal impairment.\n15. Estimated GFR must range from:\n\n    1. 15-29 mL\u002Fmin (severe renal impairment) or\n    2. 30-59 mL\u002Fmin (moderate renal impairment) or\n    3. 60-89 mL\u002Fmin (mild renal impairment) determined by the Cockcroft-Gault equation, at the Screening Visit.\n16. Stable concomitant medications for at least 21 days prior to dosing and up to the EOS visit.\n17. Systolic blood pressure (SBP) 100-180 mmHg, diastolic blood pressure (DBP) 50-105 mmHg and pulse rate 60-100 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and Baseline.\n\n    For participants with normal renal function, the following criteria must be met in addition:\n18. No clinically relevant diseases captured in medical history at Screening.\n19. No clinically relevant abnormalities on physical examination at Screening and Baseline.\n20. No clinically relevant abnormalities on clinical laboratory tests at Screening.\n21. Normal renal function confirmed by estimated creatinine clearance (eCLcr) ≥ 90 mL\u002Fmin, as determined by the Cockcroft-Gault equation, at Screening.\n22. Weight within ±15% to his\u002Fher matched participant(s) enrolled in the study.\n23. Biological sex matched to his\u002Fher matched participant(s) enrolled in the study.\n24. Age within ±10 years to his\u002Fher matched participant(s) enrolled in the study.\n25. Normal BP measured on the same arm, after 5 min in the supine position at Screening and Baseline defined as:\n\n    * SBP 90-140 mmHg, DBP 60-90 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects \\\u003C 65 years of age.\n    * SBP 95-160 mmHg, DBP 65-95 mmHg, and pulse rate 60-100 bpm (inclusive) for subjects ≥ 65 years of age.\n\nExclusion Criteria:\n\nParticipants with normal renal function and participants with mild, moderate, or severe renal impairment who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:\n\n1. Pregnant or lactating women.\n2. Participant is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for the EOS Visit and improbability of completing the clinical study.\n3. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the participant to comply with the protocol requirements\n4. History of hypersensitivity to rupatadine, desloratadine or any of the excipients, or to medicinal products with similar chemical structures.\n5. History of clinically significant lactose, galactose, or fructose intolerance.\n6. Any clinically relevant acute or chronic disease which could jeopardize the safety of the participant or impact the validity of the study results.\n7. Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).\n8. Participation in another clinical trial with an experimental drug within 2 months or 5 halflives (whichever is longer) before the Screening or in more than 2 clinical studies within 1 year prior to Screening.\n9. History or presence of clinically significant angioedema.\n10. Use of caffeine-containing beverages exceeding 800 mg per day (Section 5.3.2) at Screening.\n11. Nicotine consumption (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) from 48 h prior to Baseline (Day -1) until discharge from confinement (Day 2).\n12. Positive test result for urine alcohol and drugs of abuse (amphetamines, benzodiazepines, cannabinoids, cocaine and opiates) at Screening and Baseline.\n\n    Note: Subjects receiving stable treatment of methadone and benzodiazepines will be allowed to be enrolled in the study even if the urine drug screen test is positive.\n13. History of heart, kidney or liver transplantation.\n14. History of stroke, chronic seizures, or major neurological disorder.\n15. Active malignant neoplastic disease or carcinoma (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.\n16. Intake of any creatine supplement from Screening to EOS.\n17. Use of any of the following 2 weeks prior to investigational medicinal product (IMP) administration or 5 half-lives, whichever is longer:\n\n    1. Enzyme-modifying drugs known to induce\u002Finhibit hepatic drug metabolism (e.g., azole antifungals \\[ketoconazole, itraconazole, fluconazole, Posaconazole, voriconazole\\], macrolide antibiotics \\[erythromycin, clarithromycin\\], diltiazem, human immunodeficiency virus (HIV) protease inhibitors, nefazodone, rifampicin, phenytoin, dexamethasone, troglitazone, and barbiturates)\n    2. CYP3A4 substrates with a narrow therapeutic index (e.g. ciclosporin, tacrolimus, sirolimus, everolimus, cisapride)\n    3. Desloratadine\n18. Clinically significant abnormalities on ECG repolarization (QTcF \\> 450 ms in males and \\>470 ms in females) at Screening.\n19. Loss of 250 mL or more blood within 3 months prior to screening.\n\n    For participants with mild, moderate or severe renal impairment the additional criteria must not be met:\n20. Fluctuating or rapidly deteriorating renal function, as indicated by strongly varying or worsening of clinical and\u002For laboratory signs of renal impairment within the Screening Period.\n21. Participants requiring dialysis.\n22. History or clinical evidence of any disease (except for renal impairment) and\u002For existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of rupatadine, and\u002For the ability to complete the study.\n\n    For participants with normal renal function, the additional criteria must not be met:\n23. History or presence of a clinically relevant abnormality in any organ system, that is incapacitating, requires hospitalization, or in the opinion of the investigator makes the participant ineligible for enrollment in the study.\n24. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition that might have interfered with the absorption, distribution, metabolism, or excretion of rupatadine (appendectomy and herniotomy are allowed, cholecystectomy is not allowed).\n25. Intake of any prescribed medication (including vaccines) including over-the-counter (OTC) medication (including herbal and dietary supplements such as St John's Wort, homeopathic preparations, vitamins and minerals) that could affect the outcome of the study as judged by the Investigator, within 14 days before the administration of the IMP or less than 5 times the half-life of that medication, whichever is longer (excluding contraceptives and hormone replacement therapy).",{"count":256,"type":21},48,[24],"The purpose of this study is to assess the PK, tolerability, and safety of rupatadine (10 mg) and its active metabolites in participants with renal impairment compared to matched control participants with normal renal function.\n\nThe study duration will be up to 40 days, including Screening, Baseline, Study Period, and EOS visit assessments.\n\nRupatadine 10 mg tablet will be administered as single dose.",[27],"2025-05-26",{"date":262,"type":36},"2025-05-28",{"date":264,"type":36},"2022-11-21",{"date":266,"type":21},"2025-07",{"name":268,"class":43},"Noucor Health S.A.",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":119},"100129030","development-of-a-biomarker-panel-for-the-earlier-prediction-of-acute-kidney-injury-in-patients-with-diabetes-100129030","NCT00948116","Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes","Development of a Biomarker Panel for the Earlier Prediction of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing Coronary Revascularisation","BIOMARKERS","Inclusion Criteria:\n\n1. Age \\> 18 years, known diabetes mellitus or BM on arrival consistent with probable diagnosis of diabetes, eGFR \\\u003C60 ml\u002Fmin\n2. Undergoing a PCI procedure\n3. Agrees to the additional collection of blood and urine samples as outlined above\n4. Agrees to access of their clinical records for the collection of relevant medical data\n5. No history or signs of drug abuse\n6. Able to understand and sign the written Informed Consent Form\n7. Able and willing to follow the Protocol requirements\n\nExclusion Criteria:\n\n1. Cardiogenic shock\n2. Pregnancy\n3. Patient on renal replacement therapy (haemodialysis\u002FCAPD\u002Frenal transplant)\n4. Known clinically significant infection such as HIV, Hepatitis or TB\n5. Any patient determined not able to make a reasoned, informed consent prior to the planned interventional procedure",{"count":278,"type":21},250,"Patients living with diabetes mellitus have double the risk of kidney failure compared to patients without diabetes following use of dye in many x-rays and procedures to diagnose and treat narrowing of the arteries (blood vessels) in the heart that can lead to angina or a heart attack. Heart disease is the commonest cause of death in patients with diabetes. People with diabetes are more likely to need these tests\u002Ftreatments. By identifying those at greater risk of kidney complications we may be able to make these tests\u002Ftreatments safer and offer them to more patients with diabetes.",[281,27],"Diabetes Mellitus",[283,27,157,284,285],"Diabetes mellitus","Coronary revascularisation","eGFR \u003C60ml\u002Fmin","2024-12-05",{"date":288,"type":36},"2024-12-10",{"date":290,"type":36},"2009-06-24",{"date":292,"type":21},"2025-12-31",{"name":294,"class":247},"Barts & The London NHS Trust"]