Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Phase 2

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Mycophenolate mofetil; Drug: Azathioprine; Drug: Prednisolone

• Registration Number: NCT02949349
• Lead Sponsor: Genovate Biotechnology Co., Ltd.,

Brief 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.

Detailed Description

This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Primary Completion: 2016-12-30
• Study Completion: 2017-01-25
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Diagnosis of lupus nephritis.
• Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
• Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.

Exclusion Criteria

• Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
• Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
• Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
• Previous kidney transplant or planned transplant.
• Presence of life threatening complications such as cerebral lupus or severe infection.
• Presence of liver dysfunction.
• Presence of COPD or asthma requiring oral steroids.
• Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
• Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMF 500mg	Mycophenolate mofetil	Mycophenolate mofetil 500mg, PO BID
MMF 500mg	Prednisolone	Mycophenolate mofetil 500mg, PO BID
MMF 750mg	Prednisolone	Mycophenolate mofetil 750mg, PO BID
AZA	Prednisolone	Azathioprine 1mg/kg, PO BID
MMF 750mg	Mycophenolate mofetil	Mycophenolate mofetil 750mg, PO BID
AZA	Azathioprine	Azathioprine 1mg/kg, PO BID

Primary Outcome Measures

Name	Time	Method
Change in serum albumin	24 weeks treatment
Change in serum creatinine	24 weeks treatment
Change in spot urine protein/creatinine ratio	24 weeks treatment

Secondary Outcome Measures

Name	Time	Method
Change in spot urine protein/creatinine ratio	12 weeks treatment
Change in cholesterol	24 weeks treatment
Change in complete blood count/differential count (CBC/DC)	24 weeks treatment
Change in serum albumin	12 weeks treatment
Change in serum creatinine	12 weeks treatment
Change in triglyceride	24 weeks treatment
Change in number of subjects with doubling of serum creatinine	24 weeks treatment
Change in the average daily dose of oral prednisolone	24 weeks treatment