Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001212
Status:
COMPLETED
Last Update Posted:
2008-04-09
First Post:
1999-11-03
Brief Title:
Drug Therapy in Lupus Nephropathy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Studies have shown that up to 26 of patients with systemic lupus erythematoses nephritis may suffer from membranous lupus nephropathy The disease is characterized by high levels of protein in the urine and may eventually lead to kidney failure
This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure
Patients enrolled in the study will undergo a routine history and physical examination In addition several diagnostic tests will be conducted including chest x-ray ECG blood and urine laboratory tests
Patients will be divided and grouped according to the severity of their disease as shown by kidney function Each group will then randomly be subcategorized by different treatment plans Each treatment plan will made up of immunosuppressive medications including prednisone cyclophosphamide cyclosporin A and combinations of these drugs Patients will receive the medications as directed by the study
The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed Patients will be followed as outpatients throughout the 12 month study
This study will evaluate the effectiveness and toxic effects of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month period The major goal of this therapy is to decrease protein losses and ultimately prevent kidney failure
Patients enrolled in the study will undergo a routine history and physical examination In addition several diagnostic tests will be conducted including chest x-ray ECG blood and urine laboratory tests
Patients will be divided and grouped according to the severity of their disease as shown by kidney function Each group will then randomly be subcategorized by different treatment plans Each treatment plan will made up of immunosuppressive medications including prednisone cyclophosphamide cyclosporin A and combinations of these drugs Patients will receive the medications as directed by the study
The study will last 12 months and require patients to be admitted for two to five days before the study begins and once the study is completed Patients will be followed as outpatients throughout the 12 month study
Detailed Description:
This is a phase 2 trial to evaluate the effectiveness and toxicity of immunosuppressive drug therapy in patients with membranous lupus nephropathy over a 12 month study period Patients with renal biopsy documented membranous nephropathy will all be treated with alternate day prednisone and will be randomized to receive a no additional therapy control group b intravenous cyclophosphamide up to 10 gm per m2 body surface area every other month for 6 total doses or c oral cyclosporin A up to 200 mg per m2 body surface area daily for a total of 11 months Patients with glomerular filtration rates 25-66 mlmin will be randomized only to prednisone alone or to prednisone plus cyclophosphamide Renal function and disease activity will be monitored throughout the study physiologic measures of glomerular function GFR permselectivity will be examined at study entry and at the conclusion of the study Comparison will be made of the number of favorable outcomes of glomerular function as well as drug related toxicities achieved by each treatment group at the end of the 12th study month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 86-DK-0204 | None | None | None |