Biorepository to Support Research in Kidney Diseases

• Conditions: Acute Kidney Injury; Acute Interstitial Nephritis; Kidney Diseases

• Registration Number: NCT04343417
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Study Start: 2020-07-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-08-01
• Study Completion: 2035-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histological diagnosis	5 years	Histological diagnosis of kidney disease determined by evaluation by renal pathologists

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Yale New Haven Hospital, York Street Campus; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital Saint Raphael Campus; 🇺🇸 New Haven, Connecticut, United States