Primary Membranous Nephropathy
Conditions
Brief summary
Part 1: The primary endpoint is change from baseline in urine protein creatinine ratio (UPCR) at Week 24., Part 2: The primary endpoint is complete remission status (Yes/No) (for definition of complete remission, refer to Section 8.2.1 of the protocol) at Week 104.
Detailed description
Part 1: Treatment failure status (Yes/No) by Week 24, Part 1: Immunological response status (Yes/No) at Week 24, Part 1: Complete remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Overall remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Relapse status (Yes/No) by Week 104, Part 1: Incidence and severity of treatment-emergent adverse events, Part 2: overall remission status (Yes/No) (for definition of overall remission, refer to Section 8.2.3 of the protocol) at Week 104., Part 2: Complete remission status (Yes/No) at Week 24, Week 52, and Week 76, Part 2: Overall remission status (Yes/No) at Week24, Week 52, and Week 76, Part 2: Treatment failure status (Yes/No) by Week 24, Week 52, Week 76, and Week 104, Part 2: Time to first complete remission: the time from the date of randomization to the date of the first complete remission, Part 2: Time to first overall remission: the time from the date of randomization to the date of the first overall remission, Part 2: Relapse status (Yes/No) by Week 104, Part 2: Time to first relapse: the time from the date of first complete or partial remission to the date of the first relapse, Part 2: Patient-reported symptoms and overall health status as measured using the Kidney Disease and Quality of Life instrument™ - 36 items (KDQoL-36) and European Quality of Life 5-Dimensions 5-Levels Health Questionnaire (EQ-5D- 5L), Part 2: ≥ 30% eGFR reduction from baseline to Week 52 and Week 104 (Yes/No), Part 2: Incidence and severity of treatment-emergent adverse events
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The primary endpoint is change from baseline in urine protein creatinine ratio (UPCR) at Week 24., Part 2: The primary endpoint is complete remission status (Yes/No) (for definition of complete remission, refer to Section 8.2.1 of the protocol) at Week 104. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Treatment failure status (Yes/No) by Week 24, Part 1: Immunological response status (Yes/No) at Week 24, Part 1: Complete remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Overall remission status (Yes/No) at Week 24, Week 52, Week 76, and Week 104, Part 1: Relapse status (Yes/No) by Week 104, Part 1: Incidence and severity of treatment-emergent adverse events, Part 2: overall remission status (Yes/No) (for definition of overall remission, refer to Section 8.2.3 of the protocol) at Week 104., Part 2: Complete remission status (Yes/No) at Week 24, Week 52, and Week 76, Part 2: Overall remission status (Yes/No) at Week24, Week 52, and Week 76, Part 2: Treatment failure status (Yes/No) by Week 24, Week 52, Week 76, and Week 104, Part 2: Time to first complete remission: the time from the date of randomization to the date of the first complete remission, Part 2: Time to first overall remission: the time from the date of randomization to the date of the f | — |
Countries
Czechia, Italy, Poland, Spain