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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 22, 2014
Last verified: May 2014
  Purpose

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.


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
Diabetic Nephropathy (DN)

This Cohort will be sub-divided into to two Sub-cohorts:

A. DN-Descriptive

B. DN-Detailed

Inflammatory/autoimmune Renal Condition (IN)

This Cohort will be sub-divided into two Sub-cohorts:

A. IN-Descriptive

B. IN-Detailed


Detailed Description:

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:

  1. 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:

    1. 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.
    2. 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.
  2. 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:

  1. 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.
  2. 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.
  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 in the Descriptive Sub-cohorts will be recruited from The Rogosin Institute, NewYork Presbyterian Hospital and affiliated institutions.

Subjects in the Detailed Sub-cohorts will be recruited from The Rogosin Institute and NewYork Presbyterian Hospital.

Criteria

Inclusion Criteria:

  • DN Cohort: Males or females, age 18 and older, with presumptive diagnosis of diabetic nephropathy are eligible to participate.
  • IN Cohort: Males or females, age 18 and older. Indication for native renal biopsy based upon the clinical suspicion for an autoimmune or inflammatory nephropathy (IN-Detailed sub-cohort and IN-Descriptive sub-cohorts). Previous renal biopsy with resultant historic clinical diagnosis (IN-Descriptive sub-cohort). Willing and able to provide informed consent.

Exclusion Criteria:

  • DN Cohort: Exclusion criteria: Inability to provide informed consent.
  • IN Cohort: Exclusion criteria: 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: Shaquanda Lippman, B.A. 646-898-2753 shl9081@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 Seshan, MD         
Sub-Investigator: Robert R Riggio, MD         
Sub-Investigator: Manikkam Suthanthiran, MD         
Sub-Investigator: John CL Wang, 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

No publications provided

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: May 22, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014