Biorepository to Support Research in Kidney Diseases

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04343417

Collaborator

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

1,000

Enrollment

Locations

180.1

Anticipated Duration (Months)

500

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury Acute Interstitial Nephritis 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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Biorepository to Support Research in Kidney Diseases

Actual Study Start Date :

Jul 28, 2020

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Biorepository Participants who contributed biospecimen samples (kidney tissue, blood, urine, DNA).

Outcome Measures

Primary Outcome Measures

Histological diagnosis [5 years]
Histological diagnosis of kidney disease determined by evaluation by renal pathologists

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital, York Street Campus	New Haven	Connecticut	United States	06510
2	Yale New Haven Hospital Saint Raphael Campus	New Haven	Connecticut	United States	06511