Actively Recruiting

Age: 18Years +
All Genders
ID04334707

Kidney Precision Medicine Project to Study Acute Kidney Injury and Chronic Kidney Disease Using Kidney Biopsies and Clinical Data

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

1000

Participants Needed

13

Research Sites

N/A

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

Researchers are studying acute kidney injury (AKI) and chronic kidney disease (CKD), which are major global health issues with limited treatment options. This observational trial aims to improve understanding of these conditions by analyzing kidney biopsies and related clinical data to identify different disease types and potential targets for new treatments. The study involves collaboration among multiple centers focusing on collecting and interpreting detailed molecular and clinical information. Participants will undergo kidney biopsies to obtain tissue samples for molecular analysis, alongside other evaluations such as MRI scans and retina exams. The study includes groups with acute intrinsic kidney disease, diabetic kidney disease, hypertension-associated CKD, and type 1 diabetes with or without kidney involvement. Advanced techniques will be used to create a kidney tissue atlas and link findings to clinical features. During the study, participants will provide biospecimens like urine, blood, stool, and DNA at baseline and follow-up visits, which may be in person or remote. Their clinical records will also be reviewed periodically. Researchers will monitor biopsy-related outcomes up to six months and track kidney disease progression for up to ten years. Safety and participant well-being are prioritized throughout the study.

CONDITIONS

Brief 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) or hypertension with evidence of persistent kidney damage
  • Evidence of acute kidney injury with specific urine output or serum creatinine changes
  • Clinical diagnosis of type 1 diabetes with or at risk of chronic kidney disease
  • Willingness to undergo kidney biopsy and provide biospecimens
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Severe allergy to iodinated contrast
  • Pregnancy
  • Transplant recipient (solid organ or bone marrow)
  • Incarceration, institutionalization, or inability to participate
  • Inability to provide informed consent
  • Kidney disease from autoimmune, viral, or glomerular diseases other than diabetic or hypertension-related CKD
  • Unwillingness to receive blood transfusion if needed
  • High risk for kidney biopsy as judged by clinicians
  • Kidney depth >13 cm or size <8 cm (for percutaneous biopsy)
  • Single functioning kidney
  • Urinary tract obstruction or hydronephrosis
  • Multiple bilateral kidney cysts interfering with biopsy
  • Kidney or peri-renal infection
  • Imaging abnormalities preventing safe biopsy
  • Bleeding risks such as INR >1.4, low platelets, low hemoglobin
  • Chronic anticoagulation or inability to stop anti-platelet agents
  • Blood pressure >160/100 mmHg
  • Ventilator dependence or hypotension requiring pressor support
  • Any condition preventing safe biopsy as judged by operator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to assess eligibility and provide informed consent

Diagnostic Evaluation

Duration - Up to 8 weeks around biopsy

Participants undergo a kidney biopsy and other diagnostic procedures to collect kidney tissue and imaging data for molecular and clinical analysis.

1 kidney biopsy procedure visit and 1 retina scan visit occurring up to 6 weeks before or 8 weeks after biopsy; 1 MRI visit

Long-term Monitoring

Duration - Up to 10 years

Participants are followed through scheduled in-person and remote visits, along with periodic review of clinical data and biospecimens, to monitor kidney disease progression.

Scheduled in-person and remote study visits with periodic electronic health record reviews

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

K

Kristina Blank, MPH

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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Published Research Related To This Trial

Hemodialysis Disparities in African Americans: The Deeply Integrated Concept of Race in the Social Fabric of Our Society.

Keith C Norris, Sandra F Williams, Connie M Rhee...

https://pubmed.ncbi.nlm.nih.gov/28281281