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NCT04343417 Clinical Trial

Biorepository to Support Research in Kidney Diseases

Acute Kidney Injury Clinical Trial

Official title:
Biorepository to Support Research in Kidney Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04343417
Other study ID # 2000027890
Secondary ID 1K23DK117065-01A
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 28, 2020
Est. completion date August 1, 2035

Study information
Verified date October 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date August 1, 2035
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients scheduled to undergo a clinically indicated kidney biopsy - English 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Yale New Haven Hospital Saint Raphael Campus New Haven Connecticut
United States Yale New Haven Hospital, York Street Campus New Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Histological diagnosis Histological diagnosis of kidney disease determined by evaluation by renal pathologists 5 years
Secondary Occurrence of chronic kidney disease, end stage kidney disease or death Track outcomes in participants recruited for up to 10 years 10 years
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