Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID)
The central goal of this data repository is to collect data from a large population of patients with diabetic nephropathy and inflammatory renal conditions. This initiative will provide an opportunity to compare data from various disease states 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. Other objectives include the discovery of new molecules and molecular pathways that lead to the tissue fibrosis that invariably leads to diminished renal function. Finally, a central aim of this study is to explore the biologic mechanisms that shift the balance of fibrotic mediators to a state of anti-fibrosis.
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
Blood, urine, tissue
|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)|
Diabetic Nephropathy (DN)
This Cohort will be sub-divided into to two Sub-cohorts:
Inflammatory/autoimmune Renal Condition (IN)
This Cohort will be sub-divided into two Sub-cohorts:
The purpose of this study is to collect subject data demographic, clinical, biochemical, histological, and RNA (genetic) data that will further explore the natural history of diabetic nephropathy (DN), autoimmune nephropathies (AN), and inflammatory nephropathies (IN) in order to assess for factors that may be associated with the progression of disease, the incidence of complications (including renal failure), and the response to therapy.
This research is being done because relatively few subjects have been studied for a sufficient period to fully understand how subjects are affected over the course of their lifetime. The reason for creating this repository is to collect information about inflammatory, autoimmune, or diabetic nephropathy in order to assess for factors that may be associated with the progression of disease, the incidence of complications (including renal failure) and the response to therapy. Also, 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.
The study will have two Cohorts:
DN Cohort: Subjects with clinical diagnosis of diabetic nephropathy. Criteria for DN cohorts includes: a) Clinical diagnosis of Type 1 or 2 diabetes, b) Any of the following: microalbuminuria (>40mg/day), proteinuria (>300mg/day), impaired glomerular filtration rate (GFR), diabetic retinopathy, c) Diagnosis of diabetic nephropathy based upon renal biopsy findings.
These subjects will be subdivided into sub-cohorts: DN-Descriptive and DN-Detailed:
- Subjects in the DN-Descriptive sub-cohort will be asked to return to study clinic every six months in the first year and then once a year thereafter.
- Subjects in the DN-Detailed sub-cohort will be evaluated more frequently than the DN-Descriptive sub-cohort and will be asked to return to the study clinic every 3 months for the first two years of the protocol, then every six months thereafter. In most cases, the follow-up study visits will be conducted simultaneously with regularly scheduled clinic visits.
- IN Cohort: Subjects undergoing renal biopsies for presumed inflammatory or autoimmune renal conditions. Criteria for IN cohorts include: a) Present necessity for renal biopsy based upon standard clinical criteria, b) Previous renal biopsy leading to historic diagnosis of inflammatory or autoimmune nephritides.
These subjects will be subdivided into two sub-cohorts: IN-Descriptive and IN-Detailed:
- Subjects in the IN-Descriptive sub-cohort will be seen at the study clinic on the day of their renal biopsy and asked to return to the study clinic one month, six months and 12 months after the biopsy and then one a year thereafter. Patients with prior renal biopsy are also eligible without having to undergo repeat biopsy. In most cases, the follow up study visits will be conducted simultaneously with regularly scheduled clinic visits.
- Subjects in the IN-Detailed sub-cohort will be evaluated more frequently than the IN-Descriptive sub-cohort and will be seen at the study clinic on the day of their biopsy and asked to return to the study clinic one month after the biopsy, then every three months for the first two years of the protocol and then every six months thereafter. In most cases, the follow up study visits will be conducted simultaneously with regularly scheduled clinic visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802034
|Contact: Tina Gonsalves, BDS, MSfirstname.lastname@example.org|
|Contact: Alan Perlman, M.D.||email@example.com|
|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 Seshan, MD|
|Sub-Investigator: Manikkam Suthanthiran, MD|
|Sub-Investigator: John CL Wang, MD|
|Sub-Investigator: Safa Kalache, MD|
|Principal Investigator:||Alan S Perlman, M.D.||The Rogosin Institute|