A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH ISN/RPS 2003 CLASS III OR IV LUPUS NEPHRITIS
- Conditions
- -N118 Other chronic tubulo-interstitial nephritis-N11Other chronic tubulo-interstitial nephritisN11N118
- Registration Number
- PER-007-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age 1875 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator´s judgment
• ISN/RPS 2003 Class III or IV LN by renal biopsy performed in the 6 months prior to screening or during screening.
• Systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III or IV LN (above) and current or past positive antinuclear antibody (ANA).
• UPCR 1 on a 24-hour collection at screening.
• Receipt of at least one dose of pulse methylprednisolone IV ( 250 mg) or equivalent for treatment of the current episode of active LN during the 6 months prior to screening or during screening.
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs.
• For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm.
See protocol for more detail.
Patients who meet any of the following criteria will be excluded from study entry:
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo or within 6 weeks after the final dose of MMF Women of childbearing potential must have a negative urine pregnancy test at screening. Positive test results will be confirmed with a serum pregnancy test.
• Severe renal impairment.
• Sclerosis in 50% of glomeruli on renal biopsy
• Presence of rapidly progressive glomerulonephritis
• HIV infection
• Tuberculosis (TB) infection
See protocol for more detail.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:CRR is defined as achievement of all of the following:<br>- Urinary protein-to-creatinine ratio (UPCR)  0.5<br>- Serum creatinine  the upper limit of normal ( ULN) (as determined by the central<br>laboratory)<br>- Serum creatinine not increased from baseline by  25%<br>- No occurrence of intercurrent events<br>Rescue therapy, treatment failure, and study treatment discontinuation are<br>considered as intercurrent events.<br>Measure:Complete renal response (CRR) at Week 76<br>Timepoints:At Week 76<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:CRR with eGFR criteria is defined as achievement of all of the following:<br>- UPCR < 0.5<br>- eGFR ≥ 85% of baseline, as calculated using the Chronic Kidney Disease<br>Epidemiology Collaboration (CKD-EPI) equation<br>- No occurrence of intercurrent events.<br>Measure:Complete renal response (CRR) with estimated glomerular filtration rate (eGFR)<br>criteria at Week 76.<br><br>Timepoints:At Week 76<br>