Drug Therapy in Lupus Nephropathy

Phase 2

Completed

• Conditions: Nephrotic Syndrome; Systemic Lupus Erythematosus

• Registration Number: NCT00001212
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

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 1.0 gm per m(2) body surface area every other month for 6 total doses, or c) oral cyclosporin A up to 200 mg per m(2) body surface area daily for a total of 11 months. Patients with glomerular filtration rates 25-66 ml/min 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 Timeline

• Study Start: 1986-11
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Study Completion: 2004-09
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to complete or partial remission of proteinuria.	Within the firs year after starting protocol treatment

Secondary Outcome Measures

Name	Time	Method
Change in glomerular filtration rate	One year
Adverse Effects	For the duration of extended follow-up starting at the beginning of protocol treatment
Time to relapse of nephritic syndrome	For the duration of extended follow-up starting at the end of the 12-month protocol treatment period

Trial Locations

Locations (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); 🇺🇸 Bethesda, Maryland, United States