Immune System Related Kidney Disease
Studies of Immunologically-Mediated Kidney Diseases
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Listed as NCT00001979, this observational or N/A phase trial focuses on Kidney Disease and Nephrotic Syndrome and remains actively recruiting participants. Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), it has been updated 79 times since 1992, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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....
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.
Status Flow
Change History
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First recorded
Jun 1992
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
For direct contact, visit the study record on ClinicalTrials.gov .