NCT04343417

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
110mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jul 2020Aug 2035

First Submitted

Initial submission to the registry

April 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2035

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

April 8, 2020

Last Update Submit

August 11, 2025

Conditions

Keywords

KidneyKidney DiseaseAcute Kidney InjuryKidney biopsyKidney Biorepository

Outcome Measures

Primary Outcomes (1)

  • Histological diagnosis

    Histological diagnosis of kidney disease determined by evaluation by renal pathologists

    5 years

Secondary Outcomes (1)

  • Occurrence of chronic kidney disease, end stage kidney disease or death

    10 years

Study Arms (1)

Biorepository

Participants who contributed biospecimen samples (kidney tissue, blood, urine, DNA).

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06510, United States

Location

Yale New Haven Hospital Saint Raphael Campus

New Haven, Connecticut, 06511, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (serum, plasma, and DNA extraction), urine samples, kidney tissue sample

MeSH Terms

Conditions

Acute Kidney InjuryAcute Tubulointerstitial NephritisKidney Diseases

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dennis G Moledina, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 13, 2020

Study Start

July 28, 2020

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2035

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations