Drug Therapy in Lupus Nephropathy
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|ClinicalTrials.gov Identifier: NCT00001212|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : April 9, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Nephrotic Syndrome Systemic Lupus Erythematosus||Drug: prednisone Drug: cyclophosphamide Drug: cyclosporin A||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Official Title:||Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy|
|Study Start Date :||November 1986|
|Estimated Study Completion Date :||September 2004|
- Time to complete or partial remission of proteinuria. [ Time Frame: Within the firs year after starting protocol treatment ]
- Change in glomerular filtration rate [ Time Frame: One year ]
- Adverse Effects [ Time Frame: For the duration of extended follow-up starting at the beginning of protocol treatment ]
- Time to relapse of nephritic syndrome [ Time Frame: For the duration of extended follow-up starting at the end of the 12-month protocol treatment period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001212
|United States, Maryland|
|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Bethesda, Maryland, United States, 20892|