Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Genovate Biotechnology

Status and phase: Completed; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Prednisolone; Drug: Azathioprine; Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949349

GBL15-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

MMF 500mg

Experimental group

Description:

Mycophenolate mofetil 500mg, PO BID

Treatment:

Drug: Prednisolone

Drug: Mycophenolate mofetil

MMF 750mg

Experimental group

Description:

Mycophenolate mofetil 750mg, PO BID

Treatment:

Drug: Prednisolone

Drug: Mycophenolate mofetil

AZA

Active Comparator group

Description:

Azathioprine 1mg/kg, PO BID

Treatment:

Drug: Prednisolone

Drug: Azathioprine