Actively Recruiting

Age: 18Years +
All Genders
NCT04334707

Kidney Precision Medicine Project

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-14

1000

Participants Needed

13

Research Sites

408 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Kidney Precision Medicine Project

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of diabetes mellitus (type 1 or 2) confirmed by hemoglobin A1C �36.5% or fasting blood sugar �3126 mg/dL, or use of glucose-lowering therapy, or diagnostic code for diabetes
  • Evidence of persistent kidney damage with eGFR 30-59 mL/min/1.73m2 or eGFR �30 mL/min/1.73m2 with urine albumin �30 mg/g creatinine or urine protein �150 mg/g creatinine
  • Diagnosis of hypertension established by blood pressure readings greater than 140/90 mmHg on three occasions or use of antihypertensive medication or diagnostic code
  • For acute kidney injury, baseline eGFR greater than 45 mL/min/1.73m2 with urine output drop or serum creatinine rise or positive kidney injury biomarkers
  • Clinical diagnosis of type 1 diabetes supported by antibodies or low C-peptide, insulin use for over 1 year, and kidney damage or risk factors
  • Individuals with type 1 diabetes over 25 years duration with normal kidney function and low urine albumin (DM-resistant)
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Severe allergy to iodinated contrast
  • Pregnancy
  • Transplant recipient including solid organ and bone marrow
  • Incarcerated, institutionalized, or unable to participate
  • Unable to provide informed consent
  • Diagnosis of kidney disease from autoimmune, viral, dysproteinemia, or other non-DKD/H-CKD causes
  • Unwilling to receive blood transfusion if needed
  • High risk for kidney biopsy as judged by clinicians
  • Kidney depth over 13 cm, size less than 8 cm, solitary kidney, obstruction, cysts, infection, or other imaging abnormalities preventing safe biopsy
  • Bleeding risks including INR >1.4, low platelets, low hemoglobin, chronic anticoagulation, inability to stop certain medications
  • Blood pressure over 160/100 mmHg or unstable peri-procedure blood pressure
  • Ventilator-dependent or requiring pressor support
  • Any other condition preventing safe biopsy as judged by the operator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

University of Arizona

Tucson, Arizona, United States, 85721

Actively Recruiting

2

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

3

University of Illinois Chicago

Chicago, Illinois, United States, 60607

Actively Recruiting

4

Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

5

Boston Medical Center

Boston, Massachusetts, United States, 02115

Actively Recruiting

6

Joslin Diabetes Center

Boston, Massachusetts, United States, 48374

Actively Recruiting

7

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

8

Mayo Clinic, Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

9

Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

10

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

11

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

12

University of Texas at Southwestern

Dallas, Texas, United States, 75390

Actively Recruiting

13

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

A

Ashveena Dighe, MS, MPH

CONTACT

K

Kristina Blank, MPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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