[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glomerular-filtration-rate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glomerular-filtration-rate":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100618745","evaluation-of-protein-loading-on-measurement-of-renal-reserve-100618745",false,"NCT07335614","Evaluation of Protein Loading on Measurement of Renal Reserve","An Open Label, Single Center Study to Evaluate the Effect of Protein Loading on the Measurement of Renal Reserve Using the MediBeacon® Transdermal GFR System","Inclusion Criteria:\n\nTo be eligible for study entry, all participants must satisfy all of the following criteria:\n\n1. Age \\> 18 years - male or female\n\n   1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose\n   3. For women of child-bearing potential, the participant should have a negative pregnancy test, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization\n   4. Men will not donate sperm during the study and for 1 month following the last dose of study drug\n2. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n3. eGFR \\>30 mL\u002Fmin\u002F1.73 m\\^2\n4. Capable of fasting for at least 8 hours prior to the evaluation day\n\nExclusion Criteria:\n\n1. Current use of renin-angiotensin-aldosterone system inhibitors (RAASi) including angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACE-inhibitors) or direct renin inhibitors that can't be stopped at least 5 half-lives prior to the study day.\n2. Current use of sodium-glucose cotransporter-2 (SGLT2) inhibitors such as bexaglifloxin, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin or others that can't be stopped at least 5 half-lives prior to the study day.\n3. Currently taking any drug classified as a sympathomimetic drug such as dobutamine, dopamine, norepinephrine, epinephrine, isoproterenol or others.\n4. Current over the counter use of cold medications containing ephedrine or weight loss drugs containing ephedra alkaloids\n5. Current history of drug use involving cocaine, mephedrone, amphetamines or methamphetamine\n6. The participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer).\n7. History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)\n8. History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy).\n9. Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial.\n10. Significant scarring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin\n11. Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day\n12. Use make-up, lotions, Vaseline or other products on the upper chest on the day prior to or the day of assessments\n13. Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the subjects' ability to complete study requirements or may put the subject at increased risk or compromise the interpretability of study results.\n14. Participants with positive pregnancy test",true,"ALL","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the effect of protein loading on the measurement of renal reserve using the MediBeacon Transdermal glomerular filtration rate (tGFR) system. Adults with estimated glomerular filtration rate (eGFR) \\>30 ml\u002Fmin\u002F1.73 m\\^2 will be recruited to join the study. This is a potential new use for the tGFR for the assessment of renal reserve. Renal reserve is the increase in GFR that occurs in response to various stimuli, such as when one kidney is removed. The remaining kidney will often show an increase in GFR to compensate. Renal reserve is typically measured after a high protein meal and requires a reproducible stimulus and a repeated measurement of GFR.\n\nThe main questions it aims to answer are:\n\n* To characterize the effect of protein loading on GFR (dose response curve) as assessed by the MediBeacon Transdermal GFR System\n* To determine Renal Reserve in participants with chronic kidney disease (CKD) using the MediBeacon Transdermal GFR System\n* To demonstrate whether any change in GFR following the protein stimulus is associated with a change in cardiac output using non-invasive bioimpedance (NICaS)\n\nParticipants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and the initiation of GFR assessments, participants will ingest a high protein meal over 15-20 minutes. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace. Researchers will analyze the results to see if there is a detectable difference in fluorescence clearance rate following the high protein meal.",[27],"Glomerular Filtration Rate",[29,30],"Relmapirazin","Lumitrace","NOT_YET_RECRUITING","2026-03-31",{"date":34,"type":35},"2026-04-01","ACTUAL",{"date":37,"type":21},"2026-05",{"date":39,"type":21},"2027-01",{"name":41,"class":42},"MediBeacon","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":43},"100619836","medibeacon-transdermal-gfr-system-for-the-evaluation-of-kidney-function-in-adults-with-heart-failure-100619836","NCT07349797","MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure","An Open Label, Single-Center, Safety and Pharmacokinetic Study of Lumitrace® Injection (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR System Using the TGFR Reusable Sensor With TGFR Disposable Ring for the Evaluation of Kidney Function in Patients With Heart Failure","Inclusion Criteria:\n\n1. Age ≥18 years;\n\n   1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose\n   3. For women of child-bearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization\n   4. Men will not donate sperm during the study and for 1 month following the last dose of study drug.\n2. Diagnosis of symptomatic heart failure: Subject has symptomatic heart failure, ACC\u002FAHA Stage C or D, ambulatory or hospitalized for heart failure, adjudicated by a principal investigator, and meeting both of the following:\n\n   1. Clinical syndrome: Symptoms and\u002For signs consistent with heart failure (e.g., dyspnea, fatigue, edema, rales, elevated JVP), and\n   2. Objective evidence of heart failure (≥1 of):\n\n      * Left ventricular systolic dysfunction or other structural abnormalities (left atrial enlargement, left ventricular hypertrophy, diastolic dysfunction on echocardiography) or\n      * Hemodynamic evidence of elevated filling pressures by invasive or noninvasive assessment, or\n      * Elevated natriuretic peptides obtained within 90 days from enrollment: NT-proBNP ≥300 pg\u002FmL (BNP ≥100 pg\u002FmL) in sinus rhythm or NT-proBNP ≥900 pg\u002FmL (BNP ≥300 pg\u002FmL) in atrial fibrillation\n3. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n4. Adequate venous access sufficient to allow blood sampling per protocol requirements\n\nExclusion Criteria:\n\nTo be eligible for the study, participants must not meet any of the criteria noted below:\n\n1. Intolerance to iohexol or iodine allergy\n2. Known allergy to relmapirazin or severe hypersensitivity reactions to adhesives or related products\n3. Administration of iohexol for cross-sectional imaging within a week from the dosing visit\n4. Limb amputation\n5. Primary kidney disease (e.g., glomerulonephritis or polycystic kidney disease)\n6. Acute kidney injury (AKI) or unstable kidney function at the time of dosing visit\n7. Clinical signs of excessive volume overload (edema grade 3-4 or ascites)\n8. Significant scarring, tattoos, or alterations in pigmentation on the sternum or other sensor location areas that would alter sensor readings\n9. Use of tanning sprays, tanning products, etc. on the upper chest within 2 weeks of dosing day\n10. Use of make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing\n11. Participants who have received nephrotoxic agent or signs or symptoms suggestive of a condition that may result in acute kidney injury within two weeks of study entry.",{"count":52,"type":21},15,[24],"The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin (Lumitrace) and the MediBeacon tGFR system compared to plasma clearance measurement of GFR in adults with heart failure.\n\nThe main question it aims to answer is the comparison of the transdermal-derived GFR for each participant using the MediBeacon tGFR to their nGFRBSA measurement.\n\nParticipants will participate in a Screening visit that will take place within 15 days of the scheduled administration of Lumitrace and iohexol. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and iohexol and the initiation of GFR assessments, participants will be followed at the study center for 10-24 hours. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace and iohexol. Researchers will analyze the results to compare the tGFR values to the nGFRBSA measurements for each participant.",[27,56],"Heart Failure",[29,30],{"date":34,"type":35},{"date":60,"type":21},"2026-04",{"date":39,"type":21},{"name":41,"class":42},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":43},"100590928","the-study-on-the-effectiveness-of-68gaga-hbed-cc-diasp-petct-in-calculating-gfr-and-predicting-residual-renal-function-after-partial-nephrectomy-100590928","NCT06973798","The Study on the Effectiveness of [68Ga]Ga-HBED-CC-DiAsp PET\u002FCT in Calculating GFR and Predicting Residual Renal Function After Partial Nephrectomy","The Study on the Effectiveness of [68Ga]Ga-HBED-CC-DiAsp PET\u002FCT in Calculating Glomerular Filtration Rate and Predicting Residual Renal Function After Partial Nephrectomy","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Patients with claustrophobia or fear of radiation;\n* Women who are planning to conceive, pregnant, or breastfeeding;\n* Patients unable to lie flat for 30 minutes;\n* Patients or family members who cannot understand the conditions and objectives of the study, or who refuse to participate.","88 Years",{"count":72,"type":21},40,[24],"In subjects with different levels of renal function and no history of renal tumors, GFR is measured using \\[68Ga\\]Ga-HBED-CC-DiAsp PET\u002FCT, the Gates method, and the 99mTc-DTPA dual plasma method. The consistency between the three methods is analyzed using intra-class correlation coefficient (ICC), concordance correlation coefficient (CCC), and Bland-Altman analysis.\n\nIn patients scheduled for partial nephrectomy due to renal tumors, GFR is measured using the three methods within 2 weeks before surgery and 4±1 weeks post-surgery. The percentage of postoperative residual renal function (postoperative GFR\u002Fpreoperative GFR × 100%, hereafter referred to as RRF%) is calculated for each method. By comparing and overlaying preoperative and postoperative PET\u002FCT images, the resected renal area can be delineated on the preoperative PET\u002FCT image. Based on the preoperative PET\u002FCT and the delineated surgical area, a predictive value for postoperative GFR is calculated to obtain the predicted RRF%. A consistency analysis is then performed between the predicted RRF% and the actual RRF% measured by the three methods, using ICC, CCC, and Bland-Altman analysis to evaluate the efficacy of \\[68Ga\\]Ga-HBED-CC-DiAsp PET\u002FCT in predicting residual renal function after partial nephrectomy.",[76,27,77],"Kidney Neoplasms \u002F Surgery","Positron-Emission Tomography(PET)",[79,80,81,82],"[68Ga]Ga-HBED-CC-DiAsp","PET\u002FCT","glomerular filtration rate","partial nephrectomy","2025-05-07",{"date":85,"type":35},"2025-05-15",{"date":87,"type":21},"2025-07-01",{"date":89,"type":21},"2025-11-10",{"name":91,"class":92},"Luo Yaping","OTHER"]