An observational study in Acute Kidney Failure, Acute Kidney Insufficiency and Acute Renal Failure, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Icahn School of Medicine at Mount Sinai · 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.
Despite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by:
Non-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).
Access 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.
A number of research centers across the United States are collaborating to bring state-of-the-art technologies together to:
The KPMP is made up of three distinct, but highly interactive, activity groups:
The Kidney Precision Medicine Project (KPMP) is a prospective cohort study, whose goal is to use deep molecular phenotypes of kidney biopsies, along with longitudinally collected clinical phenotypic data, in order to develop new disease ontologies, classification systems, and treatments for acute kidney injury (AKI) and chronic kidney disease (CKD). Since its inception, the KPMP has sought out and included substantive patient-representative feedback regarding disease experience, lack of innovation in new kidney disease therapies and patient tolerance for risk levels in balance with potential benefits both to the individual and society.
The KPMP Has publicly and operationally committed itself to always put participants and their best interests first and this foundational principle informs and undergirds every facet of the study. Both AKI and CKD are conditions that impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. The network will utilize state-of-the-art methods to perform molecular interrogation of the tissue and to link the molecular data to kidney structure and clinical information in the form of a kidney tissue atlas.
Molecular and imaging data derived from kidney tissue will be integrated with clinico-pathologic and genetic information, as well as other data derived from analyses of fluid biospecimens, including peripheral blood, urine, and stool. Using advanced analytics to integrate the data, KPMP will aim to define kidney disease subgroups in molecular terms by identifying critical cells, pathways and targets for novel therapies.
Patients with AKI or CKD will be recruited from clinical care encounters (e.g., clinic visits for CKD patients, hospitalization or emergency room visits for AKI patients) and from electronic resources (e.g., existing registries, electronic health records). All study procedures are designed to optimize participant safety and will be ethically conducted, ensuring subjects fully understand the scope of the study and any possible risks.
For each participant, kidney tissue will be obtained for molecular phenotyping and clinical diagnosis. The diagnostic interpretation will be returned to the participant's primary caregiver to inform clinical care, but no treatment interventions will be prescribed by the KPMP. In addition to kidney biopsy, the study will involve collection of baseline (time of biopsy) and longitudinal biospecimens (including urine, plasma, serum, DNA and stool) and demographic, clinical, and laboratory data. Participants will be followed through scheduled in-person and remote (telephone) study visits, as well as through periodic review of electronic health records.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 151 across 772 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
The KPMP will focus on participant populations that account for large proportions of the public health burden of acute and chronic kidney diseases as evidenced by research and federal data.
For CKD, high priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD). A special population of people with long-standing type 1 diabetes (more than 25 years) who remain free of clinically-evident DKD will also be included.
For AKI, the focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN). KPMP will also include a special population of patients at risk for AKI or with early AKI captured by an open (surgical) kidney biopsy performed at the time of clinically indicated laparotomy. The rationale for including this special AKI population is that AKI often occurs early in the clinical course of conditions like sepsis, major surgery and trauma.
Chronic Kidney Disease Subjects Inclusion Criteria Diabetic kidney disease (DKD)
Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:
o Hemoglobin A1C greater than or equal to 6.5%, confirmed with a repeat test within the past year
o Fasting blood sugar greater than or equal to 126 mg/dL, confirmed with a repeat test within the past year
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:
Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)
Hypertension-associated Chronic Kidney Disease (H-CKD)
Diagnosis of hypertension (HTN) established by at least one of the following criteria:
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/min/1.73m2 on two assessments at least 3 months apart with albuminuria less than or equal to 2000 mg/g creatinine (or mg/day), or proteinuria less than or equal to 3000 mg/g creatinine (or mg/day), or ≤1+ proteinuria on urinalysis, or
Acute Kidney Injury Inclusion Criteria Baseline estimated glomerular filtration rate greater than 45 mL/min/1.73m2. Baseline defined by the median of the last three outpatient serum creatinine measurements from day 7 to 365 prior to enrollment.
AND ONE of the following criteria must be met:
Positive kidney injury urine biomarker, as defined by any of the following:
▪ NGAL level greater than or equal to 150 ng/mL by ELISA or clinical analyzer
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/ low powered field (LPF); or
Type 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:
and use of multiple daily insulin
injections or insulin pump use for >1 year
AND one of the following (CKD, at risk of CKD, or DM-R):
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/min per 1.73m2 or
o eGFR greater than or equal to 30 mL/min per 1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day)
At risk of CKD: defined by any one or more of the following:
(persistent eGFR \<75 mL/min per 1.73m2
at least 3 months apart and including the most recent measurement prior to screening, but not persistently \<60 mL/min per 1.73m2 )
o eGFR slope \<-5 mL/min/1.73m2 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
o HbA1c ≥8% on 2 occasions and T1D duration ≥5 years
o Hypertension as defined by KPMP protocol (for hypertension and CKD cohort)
o UACR ≥10 mg/g (twice, at least 3 months apart)
sTNFR1 >870 pg/mL
DM-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
General Exclusion Criteria
Safety Exclusion Criteria:
Potential 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.
Anatomic or Imaging Exclusion Criteria Kidney depth more than 13 cm (percutaneous biopsies only)
Bleeding Risk Exclusion Criteria
Blood pressure of more than 160 mmHg systolic or 100 mmHg diastolic.
○ Peri-procedure blood pressure fluctuations between 140-160 mmHg systolic and 90-100 mmHg diastolic require management, ideally to target, based on clinician/investigator judgment.
The focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN).
Procedure: Kidney Biopsy
High priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD).
Procedure: Kidney Biopsy · Other: MRI · Other: Retina Scan
Clinical diagnosis of Type 1 diabetes without evidence of other diabetes types (monogenic, secondary to pancreas disease, etc.) and has or is at risk of CKD.
Procedure: Kidney Biopsy · Other: MRI · Other: Retina Scan
Diabetes Mellitus-Resistant: A special population of people with long-standing type 1 diabetes (more than 25 years) who remain free of clinically-evident DKD will also be included.
Procedure: Kidney Biopsy · Other: Retina Scan
A kidney biopsy is a procedure that involves taking a small piece of kidney tissue for examination with a microscope. A licensed health care provider will perform a kidney biopsy.
Images will be acquired using 3.0T whole body scanner. The participant will undergo a series of sequences (e.g., BOLD, diffusion-weighted, ASL MRI, native T1, and fat fraction sequences). The participant will receive 20 mg of IV furosemide as a bolus. BOLD MRI sequences will be repeated 15 minutes after furosemide administration. ASL sequences are acquired using investigational protocols that are not FDA-approved. Siemens machines will use Body ASL PCASL Perfusion WIP 1023, Phillips will use Body ASL 2D PCASL Perfusion software, and GE machines will use Body ASL PCASL Perfusion software.
Fundus photography, fluorescein angiography, optical coherence tomography, optical coherence tomography angiography, and ophthalmologic exam and history will take place during one retina study visit. The retina visit will take place up to 6 weeks prior to the KPMP kidney biopsy OR up to 8 weeks post-biopsy.
Biopsy-related outcomes
Biopsy-related complications will be collected by KPMP study staff using standardized case report forms. Clinical utility of the biopsy results will be assessed using standardized surveys of clinical providers, and participant-reported outcomes will be assessed using standardized questionnaires. Biopsy-related outcomes data will be collected around the time of the biopsy and within the six months following procurement of the kidney biopsy.
Time frame: Immediately after the procedure for up to 6 months
Kidney disease progression outcomes
Longitudinal change in estimated glomerular filtration rate (eGFR): * Primary composite longitudinal outcome, defined by any of the following: * ESRD, defined as initiation of maintenance dialysis or kidney transplantation * Sustained decline in eGFR by 40% or more from baseline * Individual components of the primary composite outcome * Slope of eGFR change (from baseline to the latest value)
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes
Longitudinal change in urine albumin excretion defined by the following: -Slope of change in urine albumin-creatinine ratio
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes
Longitudinal change in urine albumin excretion defined by the following: -Change of Kidney Disease Improving Global Outcomes (KDIGO) albuminuria stage
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
Number of Participants with Additional Outcome Measures
* All-cause mortality, defined by death from any cause and validated through linkages with the National Death Index (NDI) * Cardiovascular events, including heart failure, myocardial infarction, cerebrovascular event, transient ischemic attack, thromboembolic event, arrhythmia, and cardiac arrest * New AKI events after KPMP enrollment * Hospital admissions and discharge diagnoses after KPMP enrollment
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
Number of Participants with Outcomes Specific to AKI
* Duration of AKI: number of days with elevated serum creatinine above baseline * Recovery of AKI: return of serum creatinine to greater than 125% of baseline by 3 months post-biopsy * ICU admissions: admissions to any intensive care unit during hospitalization * Need for dialysis: initiation and duration of any dialysis modality (CRRT, HD, or PD) * Length of hospital stay: number of days during initial AKE episode
Time frame: Through study completion (up to 10 years, depending on enrollment date of participant)
Plan to share: Yes — Available data can be found at https://www.kpmp.org/available-data. All KPMP data is available for sharing.
Supporting information: Study protocol, Icf
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