Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID) (RENAL AID)

April 1, 2025 updated by: The Rogosin Institute
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

RENAL AID is designed as an inclusive data and tissue repository that is capable of linking demographic, clinical, laboratory, histology, genetic and radiographic data into one interconnected electronic data collection instrument. It is hypothesized that by linking these typically disconnected data components into a single electronic repository, RENAL AID will be capable of discovering relationships between these otherwise disparate data sets in order to ascertain previously unknown factors and associations that contribute to the progression of disease, the incidence of complications (including renal failure) and response to therapy. Further, certain patterns of inflammatory and/or immune mediators present in the serum, whole blood and urine of subjects with renal disease may be predictive of the underlying histopathology present in renal biopsy specimens. The potential correlation of non-invasive markers with underlying histopathology in subjects undergoing renal biopsy may afford the ability to make renal diagnoses non-invasively in the future.

RENAL AID will obtain and follow clinical data on large numbers of subjects from a variety of ethnic, social and economic backgrounds in the following three research subject groups:

  1. Native Biopsy Tissue Group: This group consists of subjects for which an expectant renal biopsy is undertaken based upon clinical necessity for whom surplus tissue is available. Subjects enrolled in this group will be evaluated every 3 months for the first year following biopsy, then annually thereafter. Research whole blood, serum and urine will be obtained at these visits.
  2. Native kidney, non-tissue group: This group consists of subjects who have undergone a renal biopsy without specimen storage in the RENAL AID biorepository and/or subjects who have diabetes and concurrent kidney disease in the absence of a renal biopsy. Subjects enrolled in this group will be evaluated annually. Research whole blood, serum and urine will be obtained at these visits.
  3. Allograft tissue group: This group consists of subjects that have undergone a renal transplant and require a transplant biopsy for either surveillance (termed protocol biopsy) or "for-cause" indications. By definition, "for-cause" biopsies are performed when an unexpected clinical event occurs that warrants transplant biopsy. Such events include acute graft dysfunction, progressive decline of transplant function, proteinuria and hematuria. Subjects in this group will be evaluated at the time of the transplant biopsy and research whole blood, serum and urine will be obtained at the visit.

Additionally, as RENAL AID is designed as both a biospecimen and data repository with the objective to conduct a wide variety of diverse research based upon the data and tissue collected, there will be research investigations for which control subjects are necessary. In anticipation of this requirement, RENAL AID will have the ability to record clinical, laboratory and histology data on control subjects in the same manner as for research subjects for those studies that obligate a control group and will have the ability to store bio-specimens and tissue in the same manner as for research subjects. In these circumstances, control subjects will be consented and RENAL AID will store electronic data and biopspecimens per protocol.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nelson Chen, M.A.
  • Phone Number: 646-317-0785
  • Email: nec9039@nyp.org

Study Contact Backup

  • Name: Alan Perlman, M.D.
  • Phone Number: 212-746-1580
  • Email: alp9021@nyp.org

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • The Rogosin Institute
        • Contact:
        • Principal Investigator:
          • Alan S Perlman, MD
        • Sub-Investigator:
          • Nathaniel Berman, MD
        • Sub-Investigator:
          • James M Chevalier, MD
        • Sub-Investigator:
          • Choli Hartono, MD
        • Sub-Investigator:
          • Surya V Seshan, MD
        • Sub-Investigator:
          • Manikkam Suthanthiran, MD
        • Sub-Investigator:
          • John CL Wang, MD
        • Sub-Investigator:
          • Thomas S Parker, PhD
        • Sub-Investigator:
          • Daniel M Levine, PhD
        • Sub-Investigator:
          • David Serur, MD
        • Sub-Investigator:
          • Jun Lee, MD
        • Sub-Investigator:
          • Liu M Frank, MD
        • Sub-Investigator:
          • Meredith J Aull, PharmD
        • Sub-Investigator:
          • Nelson Chen, CRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from The Rogosin Institute, NewYork Presbyterian Hospital and affiliated institutions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in disease progression
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Rogosin Institute

Collaborators

Weill Medical College of Cornell University
New York Presbyterian Hospital

Investigators

  • Principal Investigator: Alan S Perlman, M.D., The Rogosin Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimated)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207012648

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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