A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.

NCT ID: NCT00425438

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-04-30

Brief Summary

This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mycophenolate Mofetil

Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48

Corticosteroids

Intervention Type: DRUG

0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48

Cyclophosphamide/Azathioprine

Participants received cyclophosphamide 0.75 grams per square meter (g/m\^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m\^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm\^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48.

Group Type: ACTIVE_COMPARATOR

Corticosteroids

Intervention Type: DRUG

0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48

Azathioprine

Intervention Type: DRUG

100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48

Cyclophosphamide

Intervention Type: DRUG

0.75 g/m\^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2 to maintain a minimum WBC count of ≥ 2500 per mm\^3 from Weeks 5 through 24

Interventions

Mycophenolate Mofetil

0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48

Intervention Type: DRUG

Corticosteroids

0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48

Intervention Type: DRUG

Azathioprine

100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48

Intervention Type: DRUG

Cyclophosphamide

0.75 g/m\^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2 to maintain a minimum WBC count of ≥ 2500 per mm\^3 from Weeks 5 through 24

Intervention Type: DRUG

Other Intervention Names

CellCept; Prednisolone

Eligibility Criteria

Inclusion Criteria

• adult patients, 18-75 years of age;
• systemic lupus erythematosus;
• histological diagnosis of lupus nephritis.

Exclusion Criteria

• not in need of immunosuppressive treatment (in addition to corticosteroids);
• continuous dialysis starting >2 weeks before randomization, with an anticipated duration of >8 weeks;
• previous or planned kidney transplant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing, , China

Beijing, , China

Beijing, , China

Guangzhou, , China

Guangzhou, , China

Hangzhou, , China

Nanjing, , China

Shanghai, , China

Shanghai, , China

Shanghai, , China

Shenyang, , China

Countries

China

Other Identifiers

ML19978

Identifier Type: -

Identifier Source: org_study_id