Phase 3 N=370 Randomized Treatment

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

Lupus Nephritis

Bottom Line

View on ClinicalTrials.gov: NCT00377637 ↗

Enrolled (actual)

370

Serious AEs

26.4%

Results posted

Dec 2011

Primary outcome: Primary: Induction Phase: Number of Patients Showing Treatment Response — 98; 104; 87; 81 participants — p=0.478

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Mycophenolate mofetil (MMF) (Drug); Cyclophosphamide (Drug); Azathioprine (Drug); Placebo to Azathioprine (Drug); Placebo to Mycophenolate mofetil (Drug); Corticosteroid (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Induction Phase: Number of Patients Showing Treatment Response	98; 104; 87; 81	0.478
PRIMARY Maintenance Phase: Kaplan-Meier Estimates of Percentage of Participants Treatment Failure Free, by Time Interval	98.2; 97.2; 93.7; 89.3; 89.9; 86.2	0.003 sig
SECONDARY Induction Phase: Number of Participants Achieving Complete Remission	15; 16; 170; 169	—
SECONDARY Induction Phase: Change From Baseline to Week 24 in Serum Creatinine	92.7; 108.6; 83.5; 77.6; -5.1; -18.9	—
SECONDARY Induction Phase: Change From Baseline to Week 24 in 24-hour Urine Protein	4451.4; 4208.9; 1831.6; 1599.0; -2513.7; -2510.6	—
SECONDARY Induction Phase: Change From Baseline to Week 24 in Serum Albumin	28.6; 30.5; 38.3; 38.4; 9.0; 7.5	—
SECONDARY Induction Phase: Change in Renal British Isles Lupus Assessment Group (BILAG) Score	27.1; 17.1; 34.8; 39.2; 24.9; 33.1	—
SECONDARY Induction Phase: Change From Baseline in Short-Form Health Survey (SF-36) Domain and Component Scores	6.4; 5.2; 5.7; 6.7; 16.8; 13.4	—
SECONDARY Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Deaths	0; 1	—
SECONDARY Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With End-stage Renal Disease (ESRD)	0; 3	—
SECONDARY Maintenance Phase: Events Contributing to the Primary Endpoint: Number of Participants With Sustained Doubling of Serum Creatinine	1; 5	—
SECONDARY Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Renal Flare Free, by Time Interval	98.2; 97.2; 94.6; 90.3; 90.8; 87.2	—
SECONDARY Maintenance Phase: Events Contributing to the Primary Endpoint: Kaplan-Meier Estimates of Percentage of Participants Not Receiving Rescue Therapy	100; 99.1; 98.2; 95.1; 97.2; 93.0	—
SECONDARY Maintenance Phase: Participants With Major Extra-renal Flare	7; 6	—

Summary

This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g bid) or azathioprine (2 mg/kg/day).

Eligibility Criteria

Inclusion Criteria

male or female patients, 12-75 years of age;
diagnosis of systemic lupus erythematosus;
kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;
laboratory evidence of active nephritis.

Exclusion Criteria

continuous dialysis starting >2 weeks before randomization into induction phase, and/or with an anticipated duration of >8 weeks;
previous or planned kidney transplant;
other clinically significant active medical conditions.

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Data sourced from ClinicalTrials.gov (NCT00377637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.