Kidney Precision Medicine Project (KPMP)

April 9, 2026 updated by: Jonathan Himmelfarb, Icahn School of Medicine at Mount Sinai

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:

  • Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD
  • Define disease subgroups
  • Create a kidney tissue atlas
  • Identify critical cells, pathways, and targets for novel therapies

The KPMP is made up of three distinct, but highly interactive, activity groups:

  • Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy.
  • Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue.
  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristina Blank, MPH
  • Phone Number: 206-897-1957
  • Email: blankk@uw.edu

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Frank "Chip" Brosius, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Frances (Perry) Wilson, MD
        • Sub-Investigator:
          • Dennis Moledina, MBBS, PhD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • University of Illinois Chicago
        • Contact:
        • Principal Investigator:
          • James Lash, MD
        • Principal Investigator:
          • Ana Ricardo, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Chirag Parikh, MD, PhD
        • Sub-Investigator:
          • Steve Menez, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 48374
        • Recruiting
        • Joslin Diabetes Center
        • Principal Investigator:
          • Sylvia Rosas, MD
        • Sub-Investigator:
          • Stewart Lecker, MD
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Sushrut Waikar, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Patrick Nachman, MD
        • Principal Investigator:
          • Luiza Caramori, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic, Rochester
        • Principal Investigator:
          • Yogish Kudva, MD
        • Contact:
        • Principal Investigator:
          • Aleksandra Kukla, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai
        • Contact:
        • Principal Investigator:
          • Steven Coca, DO
        • Principal Investigator:
          • Kristin Meliambro, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Amy Mottl, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Emilio Poggio, MD
        • Principal Investigator:
          • John Sedor, MD
        • Principal Investigator:
          • John O'Toole, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas at Southwestern
        • Principal Investigator:
          • Miguel Vazquez, MD
        • Principal Investigator:
          • Robert Toto, MD
        • Contact:
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Petter Bjornstad, MD
        • Principal Investigator:
          • Ian de Boer, MD
        • Contact:
          • Dawn Lum
          • Phone Number: 800-555-5555
          • Email: lumd@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

    • 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.

Hypertension-associated Chronic Kidney Disease (H-CKD)

  • 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

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.

  • 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.

AND ONE of the following criteria must be met:

  • 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:

    ▪ NGAL level greater than or equal to 150 ng/mL by ELISA or clinical analyzer

    • 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)

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:

  • 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

and use of multiple daily insulin

injections or insulin pump use for >1 year

• 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

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)

    • 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

(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)

    • 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)

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

  • 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)

General Exclusion Criteria

  • 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)

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)

  • 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.

Bleeding Risk Exclusion Criteria

  • 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.

    ○ 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.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Kidney Injury Cohort
The focus will be on acute intrinsic non-glomerular disease, primarily on acute tubular necrosis (ATN).
Procedure: Kidney Biopsy
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.
Other Names:
  • Renal Biopsy
  • Laparotomy
Chronic Kidney Diseases Cohort
High priority populations include CKD in the setting of diabetes (diabetic kidney disease, DKD) and hypertension-associated CKD (H-CKD).
Procedure: Kidney Biopsy
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.
Other Names:
  • Renal Biopsy
  • Laparotomy
Other: MRI
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.
Other: Retina Scan
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.
Type 1 Diabetes (T1D)
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
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.
Other Names:
  • Renal Biopsy
  • Laparotomy
Other: MRI
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.
Other: Retina Scan
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.
Diabetes Mellitus-Resistant (DM-R)
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
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.
Other Names:
  • Renal Biopsy
  • Laparotomy
Other: Retina Scan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopsy-related outcomes
Time Frame: Immediately 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.
Immediately after the procedure for up to 6 months
Kidney disease progression outcomes
Time Frame: Through 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)
Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes
Time Frame: Through 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
Through study completion (up to 10 years, depending on enrollment date of participant)
Kidney disease progression outcomes
Time Frame: Through 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
Through study completion (up to 10 years, depending on enrollment date of participant)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Additional Outcome Measures
Time Frame: Through study completion (up to 10 years, depending on enrollment date of participant)
  • 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
Through study completion (up to 10 years, depending on enrollment date of participant)
Number of Participants with Outcomes Specific to AKI
Time Frame: Through study completion (up to 10 years, depending on enrollment date of participant)
  • 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
Through study completion (up to 10 years, depending on enrollment date of participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Johns Hopkins University
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Washington University School of Medicine
Yale University
Columbia University
University of Pittsburgh
University of Michigan
The Cleveland Clinic
University of Illinois at Chicago
Brigham and Women's Hospital
University of Washington
Vanderbilt University
Ohio State University
University of North Carolina, Chapel Hill
University of Texas
Indiana University
The University of Texas Health Science Center at San Antonio
Harvard University
University of Arizona
Joslin Diabetes Center
Providence Health & Services
Pacific Northwest National Laboratory
Princeton University
Broad Institute of MIT and Harvard

Investigators

  • Principal Investigator: Jonathan Himmelfarb, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-24-01176
  • SITE00000750 (Other Identifier: University of Washington)
  • U2CDK114886 (U.S. NIH Grant/Contract)
  • UH3DK114861 (U.S. NIH Grant/Contract)
  • UH3DK114866 (U.S. NIH Grant/Contract)
  • UH3DK114870 (U.S. NIH Grant/Contract)
  • UH3DK114908 (U.S. NIH Grant/Contract)
  • UH3DK114915 (U.S. NIH Grant/Contract)
  • UH3DK114926 (U.S. NIH Grant/Contract)
  • UH3DK114907 (U.S. NIH Grant/Contract)
  • UH3DK114920 (U.S. NIH Grant/Contract)
  • UH3DK114923 (U.S. NIH Grant/Contract)
  • UH3DK114933 (U.S. NIH Grant/Contract)
  • UH3DK114937 (U.S. NIH Grant/Contract)
  • U01DK144994 (U.S. NIH Grant/Contract)
  • U01DK144965 (U.S. NIH Grant/Contract)
  • U01DK133095 (U.S. NIH Grant/Contract)
  • U01DK133081 (U.S. NIH Grant/Contract)
  • U01DK133097 (U.S. NIH Grant/Contract)
  • U01DK133093 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available data can be found at https://www.kpmp.org/available-data. All KPMP data is available for sharing.

IPD Sharing Time Frame

September 2019

IPD Sharing Access Criteria

De-identified IPD is public via atlas.kpmp.org. A minimal amount of clinical data is public. Non-public data can be accessed via a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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