NCT00425438

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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
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
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-01-23
• Last updated: 2014-09-25
• Results posted: 2014-09-25

Locations

11 sites across 1 country: China