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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by The Rogosin Institute
Sponsor:
Collaborators:
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01802034
First received: February 15, 2013
Last updated: February 26, 2016
Last verified: February 2016
  Purpose
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.

Condition
Kidney Diseases
Kidney Failure, Chronic
Diabetic Nephropathy
Lupus Nephritis
Glomerulonephritis, IGA

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID)

Resource links provided by NLM:


Further study details as provided by The Rogosin Institute:

Primary Outcome Measures:
  • Change in disease progression [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Blood, urine, tissue

Estimated Enrollment: 2000
Study Start Date: February 2013
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802034

Contacts
Contact: Erin Chu, M.S. 646-317-0786 elc9119@nyp.org
Contact: Alan Perlman, M.D. 212-746-1580 alp9021@nyp.org

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Principal Investigator: Alan S Perlman, MD         
Sub-Investigator: Nathaniel Berman, MD         
Sub-Investigator: Miriam H Chung, 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: Safa Kalache, 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: Jing Gao, MD         
Sponsors and Collaborators
The Rogosin Institute
New York Presbyterian Hospital
Weill Medical College of Cornell University
Investigators
Principal Investigator: Alan S Perlman, M.D. The Rogosin Institute
  More Information

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01802034     History of Changes
Other Study ID Numbers: 1207012648 
Study First Received: February 15, 2013
Last Updated: February 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Nephropathies
Glomerulonephritis
Glomerulonephritis, IGA
Kidney Diseases
Kidney Failure, Chronic
Lupus Nephritis
Renal Insufficiency
Autoimmune Diseases
Connective Tissue Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Nephritis
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on April 27, 2016