A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
- Conditions
- Primary Membranous Nephropathy
- Registration Number
- NCT04629248
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria:<br><br> - Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to<br> or during screening<br><br> - Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine<br> collection after best supportive care for >= 3 months prior to screening or<br> screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to<br> screening<br><br> - eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40<br> mL/min/1.73m^2 based on 24-hour urine collection during screening<br><br> - Other inclusion criteria may apply<br><br>Exclusion Criteria:<br><br> - Participants with a secondary cause of MN<br><br> - Pregnancy or breastfeeding<br><br> - Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to<br> randomization<br><br> - Severe renal impairment, including the need for dialysis or renal replacement<br> therapy<br><br> - Type 1 or 2 diabetes mellitus<br><br> - Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months<br> prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less<br> than 6 months prior to or during screening<br><br> - Significant or uncontrolled medical disease which, in the investigator's opinion,<br> would preclude participant participation<br><br> - Known active infection of any kind or recent major episode of infection<br><br> - Major surgery requiring hospitalization within the 4 weeks prior to screening<br><br> - Current active alcohol or drug abuse or history of alcohol or drug abuse within 12<br> months prior to screening<br><br> - Intolerance or contraindication to study therapies<br><br> - Other exclusion criteria may apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants who Achieve a Complete Remission (CR) at Week 104
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Achieve an Overall Remission at Week 104;Percentage of Participants who Achieve CR at Week 76;Time to Treatment Failure, Meeting Escape Criteria, or Relapse after Complete or Partial Remission;Time to a Sustained Reduction of Estimated Glomerular Filtration Rate (eGFR) >= 30% from Baseline;Mean Change in T-score from Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 104;Duration of CR;Change in anti-PLA2R Autoantibody Titer;Mean Change from Baseline in the PROMIS Global Assessment of Physical Health Scale at Week 104;Percentage of Participants with Adverse Events (AEs);Percentage of Participants with AEs of Special Interest (AESIs);Peripheral B-cell Counts at Specified Timepoints;Serum Concentrations of Obinutuzumab at Specified Timepoints;Prevalence of Anti-drug Antibodies (ADAs) to Obinutuzumab at Baseline;Incidence of ADAs during the study