Phase 2 N=81 Randomized Treatment

Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

Lupus Nephritis

Bottom Line

View on ClinicalTrials.gov: NCT00423098 ↗

Enrolled (actual)

Serious AEs

14.8%

Results posted

Jun 2011

Primary outcome: Primary: Number of Patients With Complete Remission — 8; 8; 34; 31 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mycophenolate sodium (Drug); Prednisone (Drug); Methylprednisolone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Complete Remission	9; 5; 33; 34	—
SECONDARY Number of Patients With Complete Remission	9; 5; 33; 34	—
SECONDARY Number of Patients With Partial Remission	16; 11; 26; 28; 20; 14	—
SECONDARY Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)	106.1; 68.2; 114.2; 73.0	—
SECONDARY Number of Patients With Moderate to Severe Flares	0; 0; 42; 39; 1; 0	—
SECONDARY Duration of Exposure to Study Medication	164.5; 157.7	—
SECONDARY Number of Patients With Adverse Events and Infections	35; 30; 7; 3; 18; 16	—
SECONDARY Number of Patients With Treatment Failure	23; 25; 19; 14; 21; 22	—
SECONDARY Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)	-7.4; -7.7; -9.7; -10.3; -10.3; -9.8	—
SECONDARY Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)	-4.8; -5.5; -8.6; -8.7; -8.6; -9.4	—

Summary

The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

Eligibility Criteria

Inclusion criteria

Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification criteria)
Aged ≥18 years,
Proliferative lupus nephritis classified as ISN/RPS class III or IV
Renal biopsy within the last 24-month preceding the study entry
Proteinuria defined as >0.5 gram urine protein per gram urine creatinine at screening and baseline
Clinical activity defined by one or more of the following changes in renal function: Serum creatinine >1.0 mg/dl (88.4 μmol/l)
Microscopic hematuria defined as >5 red cells per high power field
Presence of cellular casts

Exclusion criteria

Patients with calculated creatinine clearance <30 ml/min (using the Cockcroft-Gault formula)
Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months,
Patients having received oral or i.v. cyclophosphamide during the last 3 month
Patients having received mycophenolate mofetil (MMF) within the preceding 3 months
Use of any antibody therapy within the past 6 months
Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study.
Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment
History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures,
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00423098). 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.