Biorepository to Support Research in Kidney Diseases | NCT04343417

Studies
Biorepository to Support Research in Kidney Diseases

NCT04343417

Sponsor

Yale University

Status

Enrolling by invitation

Last Update Posted

Aug 13, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury
Acute Interstitial Nephritis
Kidney Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K23DK117065-01A1	U.S. NIH Grant/Contract		View source
R01DK128087	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Aug 1, 2030Estimated

Completion Date

Aug 1, 2035Estimated

First Submitted Date

Apr 8, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2025

Last Update Posted Date

Aug 13, 2025Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biorepository		Participants who contributed biospecimen samples (kidney tissue, blood, urine, DNA).

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis G Moledina, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale New Haven Hospital, York Street Campus		New Haven	Connecticut	06510	United States
Yale New Haven Hospital Saint Raphael Campus

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
C564356	Acute Tubulointerstitial Nephritis
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided