Recruiting

Observational Study

Sponsor:

The Rogosin Institute

Code:

NCT01802034

Conditions

Kidney Diseases

Kidney Failure, Chronic

Diabetic Nephropathy

Lupus Nephritis

Glomerulonephritis, IGA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

A central goal of this data repository is to collect data from a large population of subjects with a variety of renal disease states. Cohorts will include subjects with diabetes, inflammatory/autoimmune and transplant related renal conditions. Additionally, the repository will have the capacity to store biospecimens and electronic data in control subjects without established renal disease. This initiative will provide an opportunity to compare data from various disease states and controls with the objective of determining clinical and biological factors that predict disease progression, response to therapy and identify discriminating noninvasive clinical and biological features that predict renal biopsy findings.

Conditions

Kidney Diseases

Kidney Failure, Chronic

Diabetic Nephropathy

Lupus Nephritis

Glomerulonephritis, IGA

Study ID

NCT01802034

Start date

Feb, 2013

Status verified date

Apr, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

All Groups:

  • Males or females
  • 18 years of age and older
  • Willing and able to provide informed consent

Native Biopsy Tissue Group:

- Require an initial kidney biopsy for medical necessity

Native Kidney, Non-tissue Group:

  • Previously had a kidney biopsy and the tissue is not stored in this biorepository; or
  • Have diabetes and kidney disease and have not had a kidney biopsy

Allograft Tissue Group:

- Have undergone a renal transplant and require a transplant biopsy for either surveillance or "for-cause" indications.

Key Exclusion Criteria for all Groups:

- Inability to provide informed consent.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Native, Renal Tissue Preservation Group

Subjects who have a renal biopsy and the tissue is possessed and maintained by the RENAL AID repository.

Native, Non-tissue Preservation Group

1. Subjects who have had a renal biopsy but the tissue is not held by RENAL AID repository; and/or
2. Subjects with diabetes and renal disease who have not had a renal biopsy.

Transplant Nephropathy Group

Subjects who have had a renal transplant and require a transplant biopsy for either surveillance or "for-cause" indications.

Primary outcome measure

  • Change in disease progression [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Nelson Chen, M.A.

646-317-0785nec9039@nyp.org

Alan Perlman, M.D.

212-746-1580alp9021@nyp.org

Locations

The Rogosin Institute

Recruiting

New York, New York, United States, 10021

Contacts

Betty-Jane Sloan, M.A.

646-317-0701bjsloan@nyp.org

Principal Investigator:

Alan S Perlman, MD

More Information

Sponsor

The Rogosin Institute

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by The Rogosin Institute on 2025-04-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.