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Enrolling by invitation NCT04343417

Biorepository to Support Research in Kidney Diseases

Observational Acute Kidney Injury Acute Interstitial Nephritis Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Acute Interstitial Nephritis, Kidney Diseases. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Histological diagnosis [Time frame: 5 years]
Secondary outcome measures (1)
  • Occurrence of chronic kidney disease, end stage kidney disease or death [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 2 centers
  • Yale New Haven Hospital, York Street Campus — New Haven
  • Yale New Haven Hospital Saint Raphael Campus — New Haven

Identifiers

NCT: NCT04343417 · 2000027890 · 1K23DK117065-01A1 · R01DK128087

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗