Trial information
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Status: Completed
Protocol number: ML19978
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to compare the effect of CellCept plus corticosteroids, and cyclophosphamide plus corticosteroids followed by azathioprine, on remission rate in patients with lupus nephritis
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. Target sample size is
240.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Lupus Nephritis
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Complete remission rate Time frame: 48 weeks
Key secondary outcomes: 1. Rate of response in induction phase Time frame: 24 weeks
2. Time to complete remission Time frame: 48 weeks
3. Renal function, discontinuations, time to treatment failure, AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 01/16/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
China
