drugset / Trial / NCT02949349

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

NCT02949349

Phase 2 Completed 32 enrolled Genovate Biotechnology Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Timeline

Start
2015-07
Primary completion
2016-12-30
Completion
2017-01-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 1 mg/kg Oral
Subject Mycophenolate Mofetil Small molecule 500 mg Oral
Subject Mycophenolate Mofetil Small molecule 750 mg Oral
Background Prednisolone Other / unclassified 10 mg Oral

Indications