A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

NCT ID: NCT02081183

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-12-31

Brief Summary

This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

Conditions

Lupus Nephritis

Study Design

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

Study Groups

MMF, Prednisone

Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received mycophenolate mofetil (MMF), 1 g/day, PO, twice daily (BID) for 2 weeks; 1.5 g/day, PO, three times daily (TID) for the next 2 weeks; 2 g/day, PO, BID for the remainder of the Maintenance Phase. Participants also received prednisone, as in the Induction Phase.

Group Type: EXPERIMENTAL

Mycophenolate mofetil (MMF)

Intervention Type: DRUG

1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.

Cyclophosphamide, Induction Phase

Intervention Type: DRUG

0.5 - 1 g/m\^2 IV pulse once per month

Prednisone

Intervention Type: DRUG

1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Maintenance Cyclophosphamide, Prednisone

Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 - 1 g/m^2, IV, pulse once per month. Participants also received prednisone, 1 mg/kg/day), PO; the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, pulse once every 3 months. Participants also received prednisone, as in the Induction Phase.

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide, Maintenance Phase

Intervention Type: DRUG

0.5-1 g/m\^2 IV pulse once every 3 months

Cyclophosphamide, Induction Phase

Intervention Type: DRUG

0.5 - 1 g/m\^2 IV pulse once per month

Prednisone

Intervention Type: DRUG

1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Interventions

Mycophenolate mofetil (MMF)

1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.

Intervention Type: DRUG

Cyclophosphamide, Maintenance Phase

0.5-1 g/m\^2 IV pulse once every 3 months

Intervention Type: DRUG

Cyclophosphamide, Induction Phase

0.5 - 1 g/m\^2 IV pulse once per month

Intervention Type: DRUG

Prednisone

1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Intervention Type: DRUG

Other Intervention Names

CellCept

Eligibility Criteria

Inclusion Criteria

• adult patients >=18 years of age;
• diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

Exclusion Criteria

• patients who have received cytotoxic drugs in previous 8 weeks;
• systemic infections;
• hepatitis B or C, or HIV.

• Minimum Eligible Age: 18 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_CHAIR

Hoffmann-La Roche

Locations

Barquisimeto, , Venezuela

Caracas, , Venezuela

Countries

Venezuela

Other Identifiers

ML18989

Identifier Type: -

Identifier Source: org_study_id