Kidney Precision Medicine Project for Acute and Chronic Kidney Disease
This observational study, called the Kidney Precision Medicine Project (KPMP), is looking at acute kidney injury (AKI) and chronic kidney disease (CKD) to better understand these conditions. Researchers will collect information from participants through procedures like a kidney biopsy (taking a small tissue sample), MRI scans (detailed images of your body), and retina scans (eye exams). The goal is to develop new ways to classify and treat kidney diseases. You may be able to join if you are 18 or older and have diabetic kidney disease, which is a type of chronic kidney disease. The study aims to enroll 1000 participants. The study is ongoing, but its current status is unclear.
- Study design
- This is an observational study aiming to enroll 1000 participants. It is not testing a specific drug, but rather collecting information about kidney diseases.
- What's involved
- You would undergo a kidney biopsy, MRI scans, and retina scans. The retina visit can happen up to 6 weeks before or 8 weeks after the biopsy. You will be followed for up to 10 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for kidney disease progression outcomes for up to 10 years, depending on when they joined the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04334707
Kidney Precision Medicine Project
Recruiting
Not specifiedAges 18+ObservationalIcahn School of Medicine at Mount SinaiInvestigator-initiated
~1,000 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Kidney BiopsyMRIRetina Scan
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biopsy-related outcomes
Measured over Immediately after the procedure for up to 6 months
+3 more outcomes measured
Conditions
Where it's being run
13 sites across 11 statesMassachusetts2
Minnesota2
Arizona1
Connecticut1
Illinois1
Maryland1
New York1
North Carolina1
Study leadership
- Jonathan Himmelfarb, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of diabetes mellitus (type 1 or 2) established by at least one of the following criteria:
Use of glucose-lowering therapy (insulin or oral or other subcutaneous agents)
International Classification of Diseases (ICD) 9/10 diagnostic code for diabetes
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 30-59 mL/min/1.73m2 or
Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion greater than or equal to 30 mg/g creatinine (or mg/day) or
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)
Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m\^2.
Diagnosis of hypertension (HTN) established by at least one of the following criteria:
BP greater than 140/90 mmHg measured on three occasions over at least 1 month
Taking antihypertensive medication for blood pressure (BP) control
International Classification of Diseases (ICD) 9/10 diagnostic code for hypertension
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
Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine albumin excretion 30-2000 mg/g creatinine (or mg/day) or
Estimated glomerular filtration rate greater than or equal to 30 mL/min/1.73m2 with urine protein excretion 150-3000 mg/g creatinine (or mg/day)
Most recent eGFR must be within the past year and be ≥30 mL/min/1.73m2
If only two measurements are obtained within this window, the two results will be averaged.
If only one measurement was obtained within this window, this result will be used
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.
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.
Drop in urine output (\<500 ml/24 hours)
Any rise in serum creatinine ≥0.3 mg/dl over the baseline serum creatinine
A rise in serum creatinine \>0.1 mg/dl in a patient with high risk of AKI and at least one of the following:
Positive kidney injury urine biomarker, as defined by any of the following:
KIM1 level greater than or equal to 2.8 ng/mL by ELISA
TIMP2 x IGFBP7 greater than or equal to 2.0 by NephroCheck®
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
greater than or equal to 5 Renal Tubular Epithelial cells (RTE) per high powered field (HPF); or
greater than or equal to 5 granular cast/ low powered field (LPF)
Prior/historical test undetectable (below lower limit of assay)
C peptide \<0.6 ng/ml if estimated glomerular filtration rate (eGFR) ≥60 mL/min per 1.73m2 and use of multiple daily insulin injections or insulin pump use for \>1 year
C peptide \<2.0 ng/ml if eGFR \<60 mL/min per 1.73m2
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
eGFR greater than or equal to 30 mL/min per 1.73m2 with urine protein excretion greater than or equal to 150 mg/g creatinine (or mg/day)
Note: Most recent eGFR must be within the past year and be ≥30 mL/min per 1.73m2 .
Note: Most recent urine albumin/creatinine or urine protein/creatinine must be within the past year.
At risk of CKD: defined by any one or more of the following:
Age \<40 years and eGFR 60-75 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 )
BMI ≥30 kg/m2 with dyslipidemia (defined as triglycerides (TG) ≥150 mg/dL, high-density lipoprotein (HDL) \<40/50 mg/dL for men/women, or TG/HDL ratio \>3) or lipid lowering treatment
sTNFR1 \>870 pg/mL
DM-R: defined by all of the following:
T1D for over 25 years
Estimated glomerular filtration rate greater than or equal to 60 mL/min per 1.73m2
Urine albumin excretion less than 30 mg/g creatinine (or mg/day)
Type 1 diabetes for over 25 years
Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2
Urine albumin excretion less than 30 mg/d (or mg/g creatinine)
Exclusion
Under 18 years of age
Severe allergy to iodinated contrast
Pregnancy
Transplant recipient (includes solid transplant and bone marrow)
Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
Inability to provide informed consent
Clinical diagnosis of kidney disease from an autoimmune disease, dysproteinemia, viral disease or glomerular disease other than DKD or H-CKD
Unwilling to receive blood transfusion (if needed)
Kidney size less than 8 cm (percutaneous biopsies only)
Solitary or single functioning kidney
Evidence of urinary tract obstruction or hydronephrosis
Multiple bilateral kidney cysts that will interfere with the safe performance of the biopsy
Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney (percutaneous biopsies only)
Any other imaging abnormality, which in the judgement of the operator, prevents biopsy being performed safely.
International Normalized Ratios (INR) greater than 1.4
Platelet count less than 100,000/uL
Hemoglobin less than 8.5 g/dL
Chronic anticoagulation
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.
Blood pressure of more than 160 mmHg systolic or 100 mmHg diastolic.
Ventilator-dependent patient (does not apply to open biopsies)
Hypotension or pressor support requirement (does not apply to open biopsies)
Any other condition where in the judgement of the operator, biopsy cannot be performed safely.
What this trial measures
- Biopsy-related outcomesImmediately after the procedure for up to 6 months
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.
- Kidney disease progression outcomesThrough study completion (up to 10 years, depending on enrollment date of participant)
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)
- Kidney disease progression outcomesThrough study completion (up to 10 years, depending on enrollment date of participant)
Longitudinal change in urine albumin excretion defined by the following: -Slope of change in urine albumin-creatinine ratio
- Kidney disease progression outcomesThrough study completion (up to 10 years, depending on enrollment date of participant)
Longitudinal change in urine albumin excretion defined by the following: -Change of Kidney Disease Improving Global Outcomes (KDIGO) albuminuria stage