Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID) (RENAL AID)
Kidney Failure, Chronic
|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)|
- Change in disease progression [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|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)|
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
Transplant Nephropathy Group
Subjects who have had a renal transplant and require a transplant biopsy for either surveillance or "for-cause" indications.
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:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802034
|Contact: Erin Chu, M.S.||email@example.com|
|Contact: Alan Perlman, M.D.||firstname.lastname@example.org|
|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|
|Principal Investigator:||Alan S Perlman, M.D.||The Rogosin Institute|