Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001979
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2000-01-20
Brief Title:
Immune System Related Kidney Disease
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Immunologically-Mediated Kidney Diseases
Status:
RECRUITING
Status Verified Date:
2024-06-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 eg vitamin D lipids and endocrine function eg 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
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 eg vitamin D lipids and endocrine function eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-DK-0156 | None | None | None |