Trial information
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Status: No longer recruiting
Protocol number: ML18989
Sponsor: Roche Venezuela
Company division: Pharmaceutical
Official Scientific Title: A study to evaluate the efficacy of CellCept, administered in a sequential treatment scheme, in delaying progressive renal damage in patients with lupus nephritis.
Brief summary: This study will compare the efficacy of CellCept (0.5-2g/day po) and cyclophosphamide (0.5-1g/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 3-12 months, and the target sample size is <100 individuals. Target sample size is 45.
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. Creatinine clearance, urinary protein, serum creatinine and serum albumin.
Key secondary outcomes: 1. Adverse events, lab tests, vital signs.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: March, 2006
Trial registration date: 05/17/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Venezuela
