Biorepository to Support Research in Kidney Diseases

August 11, 2025 updated by: Yale University
To support advances in the understanding of pathophysiology and therapies of kidney diseases by creating a BioBank of kidney tissue, DNA, plasma, and urine from patients with kidney diseases.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

A biorepository of human samples to support research to advance understanding of human kidney diseases will be created. Clinically, kidney diseases are detected by blood and urine laboratory tests. However, the underlying cause of kidney disease is often not clear on blood and urine tests. In such cases, a clinician may choose to perform a kidney biopsy to establish the diagnosis. Patients who are scheduled to undergo a kidney biopsy will be invited to participate in this proposed study.

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 Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital, York Street Campus
      • New Haven, Connecticut, United States, 06511
        • Yale New Haven Hospital Saint Raphael Campus

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The biorepository is a prospective cohort study of subjects with kidney diseases, who are scheduled to undergo a kidney biopsy at Yale New Haven Hospital (York St. or St. Raphael's campus) as part of the routine clinical care and agree to participate in this study.

Description

Inclusion Criteria:

  • Patients scheduled to undergo a clinically indicated kidney biopsy
  • English or Spanish speaking

Exclusion Criteria:

  • Under 18 years or age
  • Known pregnancy
  • Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
  • Inability to provide informed consent

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Biorepository
Participants who contributed biospecimen samples (kidney tissue, blood, urine, DNA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histological diagnosis
Time Frame: 5 years
Histological diagnosis of kidney disease determined by evaluation by renal pathologists
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of chronic kidney disease, end stage kidney disease or death
Time Frame: 10 years
Track outcomes in participants recruited for up to 10 years
10 years

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Dennis G Moledina, MD, Yale University

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)

July 28, 2020

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2035

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (Actual)

April 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027890
  • 1K23DK117065-01A1 (U.S. NIH Grant/Contract)
  • R01DK128087 (U.S. NIH Grant/Contract)

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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