[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-renal-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-renal-insufficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100388202","kidney-precision-medicine-project-100388202",false,"NCT04334707","Kidney Precision Medicine Project","KPMP","Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)\n\n* Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:\n\n  o Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year\n\n  o Fasting blood sugar greater than or equal to 126 mg\u002FdL, confirmed with a repeat test within the past year\n  * Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)\n  * International Classification of Diseases (ICD) 9\u002F10 diagnostic code for diabetes\n* Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function:\n\n  * Estimated glomerular filtration rate 30-59 mL\u002Fmin\u002F1.73m2 or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine albumin excretion greater than or equal to 30 mg\u002Fg creatinine (or mg\u002Fday) or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine protein excretion greater than or equal to 150 mg\u002Fg creatinine (or mg\u002Fday)\n\n    * Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin\u002F1.73m\\^2.\n\nHypertension-associated Chronic Kidney Disease (H-CKD)\n\n* Diagnosis of hypertension (HTN) established by at least one of the following criteria:\n\n  * BP greater than 140\u002F90 mmHg measured on three occasions over at least 1 month\n  * Taking antihypertensive medication for blood pressure (BP) control\n  * International Classification of Diseases (ICD) 9\u002F10 diagnostic code for hypertension\n* Evidence of persistent kidney damage, manifested as any of the following present on at least two assessments at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: Estimated glomerular filtration rate 30-59 mL\u002Fmin\u002F1.73m2 on two assessments at least 3 months apart with albuminuria less than or equal to 2000 mg\u002Fg creatinine (or mg\u002Fday), or proteinuria less than or equal to 3000 mg\u002Fg creatinine (or mg\u002Fday), or ≤1+ proteinuria on urinalysis, or\n\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine albumin excretion 30-2000 mg\u002Fg creatinine (or mg\u002Fday) or\n  * Estimated glomerular filtration rate greater than or equal to 30 mL\u002Fmin\u002F1.73m2 with urine protein excretion 150-3000 mg\u002Fg creatinine (or mg\u002Fday)\n* Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin\u002F1.73m2\n\nAcute Kidney Injury Inclusion Criteria Baseline estimated glomerular filtration rate greater than 45 mL\u002Fmin\u002F1.73m2. Baseline defined by the median of the last three outpatient serum creatinine measurements from day 7 to 365 prior to enrollment.\n\n* If only two measurements are obtained within this window, the two results will be averaged.\n* If only one measurement was obtained within this window, this result will be used\n* If baseline is missing, the potential participant can be enrolled with an estimated baseline, but only if there is no past medical history of chronic kidney disease.\n* If the AKI RS PI believes that the baseline serum creatinine under or over-estimates baseline, a unanimous vote of AKI site PIs can confirm eligibility based on a review of deidentified serum creatinine values provided by the site PI.\n\nAND ONE of the following criteria must be met:\n\n* Drop in urine output (\\\u003C500 ml\u002F24 hours)\n* Any rise in serum creatinine ≥0.3 mg\u002Fdl over the baseline serum creatinine\n* A rise in serum creatinine \\>0.1 mg\u002Fdl in a patient with high risk of AKI and at least one of the following:\n* Positive kidney injury urine biomarker, as defined by any of the following:\n\n  ▪ NGAL level greater than or equal to 150 ng\u002FmL by ELISA or clinical analyzer\n  * KIM1 level greater than or equal to 2.8 ng\u002FmL by ELISA\n  * TIMP2 x IGFBP7 greater than or equal to 2.0 by NephroCheck®\n* Urine microscopy suggestive of acute tubular necrosis defined as a urine microscopy score of greater than or equal to 2. \\[25\\] ▪ greater than or equal to 1 Renal Tubular Epithelial cells (RTE) per high powered field (HPF) AND greater than or equal to 1 granular cast\u002F low powered field (LPF); or\n\n  * greater than or equal to 5 Renal Tubular Epithelial cells (RTE) per high powered field (HPF); or\n  * greater than or equal to 5 granular cast\u002F low powered field (LPF)\n\nType 1 Diabetes Inclusion Criteria Clinical diagnosis of T1D without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.), reviewed and approved by KPMP site endocrinologist, and supported by at least one of the following: One or more positive antibodies associated with T1D • Low C-peptide, defined as at least one of the following:\n\n* Prior\u002Fhistorical test undetectable (below lower limit of assay)\n* C peptide \\\u003C0.6 ng\u002Fml if estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin per 1.73m2 and use of multiple daily insulin injections or insulin pump use for \\>1 year\n* C peptide \\\u003C2.0 ng\u002Fml if eGFR \\\u003C60 mL\u002Fmin per 1.73m2\n\nand use of multiple daily insulin\n\ninjections or insulin pump use for \\>1 year\n\n• Diabetes mellitus diagnosis for 5 years and complex insulin defined by multiple daily insulin injections ( 3 or more) or basal insulin injection plus inhaled insulin for meals or insulin pump therapy \\> 1 year continuously\n\nAND one of the following (CKD, at risk of CKD, or DM-R):\n\n* CKD: Evidence of persistent kidney damage, manifest as any of the following present on at least two clinic assessments prior to enrollment and at least 3 months apart and excluding people with acute medical illnesses and changing kidney function: o eGFR 30-59 mL\u002Fmin per 1.73m2 or\n\n  o eGFR greater than or equal to 30 mL\u002Fmin per 1.73m2 with urine albumin excretion greater than or equal to 30 mg\u002Fg creatinine (or mg\u002Fday)\n  * eGFR greater than or equal to 30 mL\u002Fmin per 1.73m2 with urine protein excretion greater than or equal to 150 mg\u002Fg creatinine (or mg\u002Fday)\n  * Note: Most recent eGFR must be within the past year and be ≥30 mL\u002Fmin per 1.73m2 .\n  * Note: Most recent urine albumin\u002Fcreatinine or urine protein\u002Fcreatinine must be within the past year.\n* At risk of CKD: defined by any one or more of the following:\n\n  * Age \\\u003C40 years and eGFR 60-75 mL\u002Fmin per 1.73m2\n\n(persistent eGFR \\\u003C75 mL\u002Fmin per 1.73m2\n\n* at least 3 months apart and including the most recent measurement prior to screening, but not persistently \\\u003C60 mL\u002Fmin per 1.73m2 )\n\n  o eGFR slope \\\u003C-5 mL\u002Fmin\u002F1.73m2 per year, calculated using all available outpatient serum creatinine values over ≥3 years prior to screening, excluding those obtained during acute illness, and including ≥1 creatinine measurement ≥3 years prior to screening\n\n  o HbA1c ≥8% on 2 occasions and T1D duration ≥5 years\n\n  o Hypertension as defined by KPMP protocol (for hypertension and CKD cohort)\n\n  o UACR ≥10 mg\u002Fg (twice, at least 3 months apart)\n  * BMI ≥30 kg\u002Fm2 with dyslipidemia (defined as triglycerides (TG) ≥150 mg\u002FdL, high-density lipoprotein (HDL) \\\u003C40\u002F50 mg\u002FdL for men\u002Fwomen, or TG\u002FHDL ratio \\>3) or lipid lowering treatment\n  * sTNFR1 \\>870 pg\u002FmL\n\n    * DM-R: defined by all of the following:\n  * T1D for over 25 years\n  * Estimated glomerular filtration rate greater than or equal to 60 mL\u002Fmin per 1.73m2\n  * Urine albumin excretion less than 30 mg\u002Fg creatinine (or mg\u002Fday)\n\nDM-R Inclusion Criteria A special population of people with long-standing type 1 diabetes (\\>25 years) who remain free of clinically-evident DKD (i.e. DKD \"resilient\" or \"DM-R\" individuals) will also be included. Study of the DKD resilient population using KPMP protocols offers a unique opportunity to identify protective factors against complications of diabetes mellitus. Diabetic Kidney Disease Resilient individuals are defined as individuals with diabetes for more than 25 years that are free from clinical nephropathy\n\n* Type 1 diabetes for over 25 years\n* Estimated glomerular filtration rate greater than or equal to 60 mL\u002Fmin\u002F1.73m2\n* Urine albumin excretion less than 30 mg\u002Fd (or mg\u002Fg creatinine)\n\nGeneral Exclusion Criteria\n\n* Under 18 years of age\n* Severe allergy to iodinated contrast\n* Pregnancy\n* Transplant recipient (includes solid transplant and bone marrow)\n* Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)\n* Inability to provide informed consent\n* Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD\n* Unwilling to receive blood transfusion (if needed)\n\nSafety Exclusion Criteria:\n\nPotential participants will be excluded if the risk of kidney biopsy is considered too high by either the clinicians caring for the potential participant or the investigators at the RS.\n\nAnatomic or Imaging Exclusion Criteria Kidney depth more than 13 cm (percutaneous biopsies only)\n\n* Kidney size less than 8 cm (percutaneous biopsies only)\n* Solitary or single functioning kidney\n* Evidence of urinary tract obstruction or hydronephrosis\n* Multiple bilateral kidney cysts that will interfere with the safe performance of the biopsy\n* Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney (percutaneous biopsies only)\n* Any other imaging abnormality, which in the judgement of the operator, prevents biopsy being performed safely.\n\nBleeding Risk Exclusion Criteria\n\n* International Normalized Ratios (INR) greater than 1.4\n* Platelet count less than 100,000\u002FuL\n* Hemoglobin less than 8.5 g\u002FdL\n* Chronic anticoagulation\n* Inability to withdraw aspirin, clopidogrel, cilostazol, or similar anti-platelet agents for at least 7 days prior to biopsy (unless bleeding time is normal before open surgical biopsy); clinical judgement will be used in the case of nonsteroidal anti-inflammatory drugs (NSAID) exposure occurring less than 7 days before percutaneous biopsy.\n* Blood pressure of more than 160 mmHg systolic or 100 mmHg diastolic.\n\n  ○ Peri-procedure blood pressure fluctuations between 140-160 mmHg systolic and 90-100 mmHg diastolic require management, ideally to target, based on clinician\u002Finvestigator judgment.\n* Ventilator-dependent patient (does not apply to open biopsies)\n* Hypotension or pressor support requirement (does not apply to open biopsies)\n* Any other condition where in the judgement of the operator, biopsy cannot be performed safely.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD.\n\nDespite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by:\n\nNon-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs).\n\nAccess to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.\n\nA number of research centers across the United States are collaborating to bring state-of-the-art technologies together to:\n\n* Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD\n* Define disease subgroups\n* Create a kidney tissue atlas\n* Identify critical cells, pathways, and targets for novel therapies\n\nThe KPMP is made up of three distinct, but highly interactive, activity groups:\n\n* Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy.\n* Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue.\n* Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Acute Kidney Failure","Acute Kidney Insufficiency","Acute Renal Failure","Acute Renal Injury","Acute Renal Insufficiency","Kidney Failure, Acute","Kidney Insufficiency, Acute","Renal Failure, Acute","Renal Insufficiency, Acute","Chronic Kidney Diseases","Chronic Kidney Insufficiency","Chronic Renal Diseases","Chronic Renal Insufficiency","Kidney Insufficiency, Chronic","Type 1 Diabetes (T1D)","RECRUITING","2026-04-09",{"date":42,"type":43},"2026-04-14","ACTUAL",{"date":45,"type":43},"2019-09-01",{"date":47,"type":20},"2027-06-30",{"name":49,"class":50},"Icahn School of Medicine at Mount Sinai","OTHER",13,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100608559","evaluation-of-the-impact-of-an-alteration-of-nad-metabolism-on-the-renal-prognosis-of-patients-admitted-to-intensive-care-ni-aki-100608559","NCT07203131","Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care (NI-AKI)","Evaluation of the Impact of an Alteration of NAD+ Metabolism on the Renal Prognosis of Patients Admitted to Intensive Care","NI-AKI","Inclusion Criteria:\n\n* Patient, male or female aged over 18,\n* Patient admitted to intensive care for a reason with a high risk of ARI: shock, sepsis, cardio-circulatory arrest, post-operative unscheduled surgery, post-operative cardiac surgery,\n* Patient with normal renal function on admission,\n* Patient affiliated to or beneficiary of a social security scheme,\n* Patient having been informed and having given his\u002Fher free, informed and written consent\n\nExclusion Criteria:\n\n* Minor patient,\n* History of chronic kidney disease,\n* History of kidney transplant,\n* Admission for a reason with a low risk of ARI (neuroresuscitation, voluntary drug intoxication with anxiolytics - antidepressants - psychotropic drugs),\n* Acute non-infectious respiratory failure, (scheduled surgery other than cardiac surgery)\n* Patient hospitalized without consent,\n* Patient in a period of exclusion due to another research still in progress at the time of inclusion,\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,\n* Pregnant, breastfeeding or parturient woman.",{"count":61,"type":20},150,"INTERVENTIONAL",[64],"NA","Among all patients admitted to intensive care, it is estimated that more than half of them are exposed during their stay to acute renal failure (ARF). Impacting the vital prognosis to short term, the occurrence of renal failure is not without consequences in intensive care survivors, presenting an increased risk of death mainly mediated by an excess risk with regard to chronic kidney disease and\u002For certain cardiovascular pathologies.\n\nMalnutrition, particularly vitamin deficiency, has already been reported as a risk factor for AKI. Studies on two models (animal and human) have recently highlighted the importance of NAD+ production failure in the onset of renal failure.\n\nNAD+ synthesis can be done from tryptophan or via a salvage pathway from vitamin PP.\n\nIn a phase 2 study in patients undergoing cardiac surgery, vitamin B3 supplementation was accompanied by a reduction in the occurrence of AKI and a limitation of the duration \u002F intensity of renal dysfunction.\n\nThis innovative research aims to identify an alteration in the metabolic pathway of NAD+ production as a risk factor for AKI in intensive care patients. This would be the first study to address this issue in this specific population.\n\nThe main objective of this research is to describe the association between the urinary Quinolinate\u002FTryptophan ratio on admission and the occurrence of acute renal failure in patients admitted to intensive care unit.",[28,67],"NAD","2025-09-29",{"date":70,"type":43},"2025-10-02",{"date":72,"type":43},"2025-03-17",{"date":74,"type":20},"2025-12-05",{"name":76,"class":50},"Ramsay Générale de Santé",1]