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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

NCT02949349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mycophenolate mofetil

Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.

DRUG

Azathioprine

Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.

DRUG

Prednisolone

Daily dose not more than 10mg, orally, for 24 weeks.

Sponsors & Collaborators

  • Genovate Biotechnology Co., Ltd.,

    lead INDUSTRY

Principal Investigators

  • Ming-Han Chen, M.D., Ph.D. · Taipei Veterans General Hospital, Taiwan, R.O.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-12-30
Completion
2017-01-25

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02949349 on ClinicalTrials.gov