Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00001979 |
| Other study ID # |
920156 |
| Secondary ID |
92-DK-0156 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 1992 |
Study information
| Verified date |
June 14, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Meryl A Waldman, M.D. |
| Phone |
(301) 451-6990 |
| Email |
waldmanm[@]mail.nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis,
membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue
disorders.
This study will allow researchers to admit and follow patients suffering from autoimmune
diseases of the kidney. It will attempt to provide information about the causes and specific
abnormalities associated with autoimmune kidney disease.
Patients with kidney disease as a result of their immune system, and patients with diseases
of the immune system who may later develop kidney disease, will be potential subjects for
this study.
Patients will undergo a history and physical examination, and standard laboratory test to
more closely understand the causes, signs, symptoms, and responses to medication of these
diseases. Based on these evaluations the patients may qualify as candidates for other
experimental studies. At any time these patients may be asked to submit blood or urine
samples for further research.
Description:
Study Description:
This study evaluates participants with known or suspected immunologically-mediated kidney
diseases, including but not limited to nephrotic syndrome, glomerulonephritis, membranous
nephropathy, lupus nephritis, and nephritis associated with other systemic or connective
tissue disorders. Participants who have immunologically-mediated diseases with potential for
kidney disease will be evaluated as well. Studies will include characterization of the
clinical and laboratory features of these disorders, studies of natural history and
complications, evaluation of responses to standard treatment. Blood and urine samples will be
collected for immunological research conducted under this protocol.
Objectives:
Primary:
-To collect samples and data obtained during standard clinical care that can be used to
better understand rare forms of immunologically-mediated renal disorders, atypical renal
disease that have not been fully characterized, and to allow for future research studies.
Exploratory:
- Characterize immunologically-mediated kidney diseases with regard to immune
dysregulation, immune cell populations and role of complement activation.
- Development of assays for novel antibodies.
- Search for additional antibodies involved in the pathogenesis of membranous nephropathy
and other glomerular diseases.
- Assess changes in metabolic (e.g. vitamin D, lipids) and endocrine function (e.g.
thyroid, adrenal function) during the evolution of the nephrotic state, during treatment
and during remission.
- Identify disease-causing memory B cells in participants with membranous nephropathy and
correlation with membranous nephropathy relapse. Assess biological effects of
phospholipase A2-receptor antibody epitope on the isolated memory B-cells.
- Compare immune cell types, including B and T cell populations and cell type specific
markers in the pathogenesis of immune-mediated kidney disease.
- Compare changes in metabolome and proteome of urine and blood during the nephrotic
syndrome, during treatment and in remission.
- Computational analysis of renal structures which may provide predictive methods that
would discriminate progressors from non-progressors beyond sclerosis in membranous
nephropathy.
