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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)