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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00423098
• Date of registration: 16/01/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
• Scientific title: A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
• Date of first enrolment: February 2007
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00423098
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Colombia, France, Germany, Greece, Hungary, Italy, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Methylprednisolone

Drug: Prednisone

Drug: Mycophenolate sodium

Primary Outcome(s)

Number of Patients With Complete Remission [Time Frame: 24 Weeks]

Secondary Outcome(s)

Cumulative Dose of Prednisone Equivalent Corticosteroids (CS) [Time Frame: 12 Weeks and 24 Weeks]

Number of Patients With Adverse Events and Infections [Time Frame: 24 weeks]

Number of Patients With Complete Remission [Time Frame: 12 Weeks]

Number of Patients With Treatment Failure [Time Frame: 12 Weeks and 24 Weeks]

Number of Patients With Moderate to Severe Flares [Time Frame: 12 and 24 weeks]

Number of Patients With Partial Remission [Time Frame: Baseline to 12 and 24 weeks]

Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) [Time Frame: From Baseline to week 4, week 12 and week 24]

Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG) [Time Frame: From Baseline to week 4, week 12 and week 24]

Duration of Exposure to Study Medication [Time Frame: 24 weeks]

Secondary ID(s)

CERL080A2420

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00423098