complement 3 glomerulopathy
Conditions
Brief summary
Primary endpoint for adult participants: - Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) Primary endpoint for adolescent participants: - Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection).
Detailed description
Secondary endpoint for adult participants: - Change from baseline in eGFR., Secondary endpoint for adult participants: - A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit., Secondary endpoint for adult participants: - Change from baseline in disease total activity score in a renal biopsy., Secondary endpoint for adult participants: - Change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) score., Secondary endpoint for adult participants: - Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE., Secondary endpoint for adolescent participants: - Change from baseline in eGFR., Secondary endpoint for adolescent participants: - A participant meets the requirements of the composite renal endpoint if he/she satisfies the following criteria at the 6-month time point: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit., Secondary endpoint for adolescent participants: - Change from baseline to 6 months in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score., Secondary endpoint for adolescent participants: - Occurrence of clinically significant vital signs, ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue) during the double-blind period of the study.
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint for adult participants: - Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) Primary endpoint for adolescent participants: - Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint for adult participants: - Change from baseline in eGFR., Secondary endpoint for adult participants: - A participant meets the requirements of the composite renal endpoint if he/she satisfies: (1) a stable or improved eGFR compared to the baseline visit (≤15% reduction in eGFR), and (2) a ≥50% reduction in UPCR compared to the baseline visit., Secondary endpoint for adult participants: - Change from baseline in disease total activity score in a renal biopsy., Secondary endpoint for adult participants: - Change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT Fatigue) score., Secondary endpoint for adult participants: - Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE., Secondary endpoint for adolescent participants: - Change from baseline in eGFR., Secondary endpoint for adoles | — |
Countries
France, Germany, Greece, Italy, Netherlands, Slovakia, Spain
Outcome results
None listed