Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01802034 |
| Other study ID # |
1207012648 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2013 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
February 2024 |
| Source |
The Rogosin Institute |
| Contact |
Nelson Chen, M.A. |
| Phone |
646-317-0785 |
| Email |
nec9039[@]nyp.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
