Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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.

Study Overview

• Status: Completed
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Mycophenolate mofetil; Drug: Prednisolone; Drug: Azathioprine

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMF 500mg; Mycophenolate mofetil 500mg, PO BID	Drug: Mycophenolate mofetil; Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.; Other Names: Mycocep Capsules; Drug: Prednisolone; Daily dose not more than 10mg, orally, for 24 weeks.
Experimental: MMF 750mg; Mycophenolate mofetil 750mg, PO BID	Drug: Mycophenolate mofetil; Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.; Other Names: Mycocep Capsules; Drug: Prednisolone; Daily dose not more than 10mg, orally, for 24 weeks.
Active Comparator: AZA; Azathioprine 1mg/kg, PO BID	Drug: Prednisolone; Daily dose not more than 10mg, orally, for 24 weeks.; Drug: Azathioprine; Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.; Other Names: Imuran Azathioprine Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change in serum albumin	12 weeks treatment
Change in serum creatinine	12 weeks treatment
Change in spot urine protein/creatinine ratio	12 weeks treatment
Change in cholesterol	24 weeks treatment
Change in triglyceride	24 weeks treatment
Change in complete blood count/differential count (CBC/DC)	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

Collaborators and Investigators

• Sponsor: Genovate Biotechnology Co., Ltd.,
• Investigators: Principal Investigator: Ming-Han Chen, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan, R.O.C.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus; Mycophenolate Mofetil; Prednisolone; Maintenance Therapy; Lupus Nephritis; Azathioprine; Serum albumin; Serum creatinine; Spot urine protein/creatinine ratio
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Prednisolone; Azathioprine; Mycophenolic Acid
• Other Study ID Numbers: GBL15-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No