Clinical trial NCT02949349: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Official title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Nephritis
Keywords: Systemic Lupus Erythematosus
Lupus Nephritis
Mycophenolate Mofetil
Azathioprine
Maintenance Therapy
Prednisolone
Serum albumin
Serum creatinine
Spot urine protein/creatinine ratio
Lead sponsor: Genovate Biotechnology Co., Ltd.,
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum albumin
timeFrame: 24 weeks treatment
measure: Change in serum creatinine
timeFrame: 24 weeks treatment
measure: Change in spot urine protein/creatinine ratio
timeFrame: 24 weeks treatment
Secondary outcomes:
measure: Change in serum albumin
timeFrame: 12 weeks treatment
measure: Change in serum creatinine
timeFrame: 12 weeks treatment
measure: Change in spot urine protein/creatinine ratio
timeFrame: 12 weeks treatment
measure: Change in cholesterol
timeFrame: 24 weeks treatment
measure: Change in triglyceride
timeFrame: 24 weeks treatment
measure: Change in complete blood count/differential count (CBC/DC)
timeFrame: 24 weeks treatment
measure: Change in number of subjects with doubling of serum creatinine
timeFrame: 24 weeks treatment
measure: Change in the average daily dose of oral prednisolone
timeFrame: 24 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan, R.O.C.
name: Ming-Han Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: