Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-01-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MMF 500mg

Mycophenolate mofetil 500mg, PO BID

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

MMF 750mg

Mycophenolate mofetil 750mg, PO BID

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

AZA

Azathioprine 1mg/kg, PO BID

Group Type ACTIVE_COMPARATOR

Azathioprine

Intervention Type DRUG

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

Prednisolone

Intervention Type DRUG

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

Interventions

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Mycophenolate mofetil

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

Intervention Type DRUG

Azathioprine

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

Intervention Type DRUG

Prednisolone

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

Intervention Type DRUG

Other Intervention Names

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Mycocep Capsules Imuran Azathioprine Tablets

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No