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

Novartis

Status and phase: Completed; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Methylprednisolone; Drug: Prednisone; Drug: Mycophenolate sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00423098

CERL080A2420

Details and patient eligibility

About

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)

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

Standard dose

Experimental group

Description:

Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.

Treatment:

Drug: Mycophenolate sodium

Drug: Methylprednisolone

Drug: Prednisone

Low dose

Active Comparator group

Description:

Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.

Treatment:

Drug: Mycophenolate sodium

Drug: Methylprednisolone

Drug: Prednisone