Clinical trial NCT01802034: Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID)
Official title: Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Diseases
Kidney Failure, Chronic
Diabetic Nephropathy
Lupus Nephritis
Glomerulonephritis, IGA
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Weill Medical College of Cornell University
First posted: 2013-03-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from The Rogosin Institute, NewYork Presbyterian Hospital and affiliated institutions.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change in disease progression
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: The Rogosin Institute
name: Alan S Perlman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: