CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed
Drug / intervention
prednisone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001212
NCT00001212Phase 2Completed

Immunosuppressive Drug Therapy in Membranous Lupus Nephropathy

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Nov 4, 1999·Updated Apr 9, 2008

In Brief

A Phase 2 clinical trial evaluating prednisone, cyclophosphamide, and 1 other intervention for Nephrotic Syndrome and Systemic Lupus Erythematosus. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartNov 1, 1986
Study CompletionSep 1, 2004
TodayJul 2, 2026
Posted 26.7 years ago

Interventions

prednisonedrug

cyclophosphamidedrug

cyclosporin Adrug