NCT02081183

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

A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Cyclophosphamide, Maintenance Phase	0.5-1 g/m\^2 IV pulse once every 3 months
DRUG	Cyclophosphamide, Induction Phase	0.5 - 1 g/m\^2 IV pulse once per month
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2014-03-07
• Last updated: 2014-07-17
• Results posted: 2014-07-17

Locations

2 sites across 1 country: Venezuela