Focal segmental glomerulosclerosis (FSGS)
Conditions
Brief summary
Phase 2: Evaluate the efficacy of pegcetacoplan in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR) Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR)
Detailed description
Phase 2: Evaluate the efficacy of pegcetacoplan in terms of change from baseline in log-transformed urine albumin to creatinine ratio (uACR) Phase 3: Change from Baseline in log-transformed urine protein to creatinine ratio (uPCR); Proportion of participants achieving Complete Remission; Slope of estimated Glomerular Filtration Rate (eGFR)
Interventions
DRUGPegcetacoplan matching placebo is a sterile solution of 10 mM acetate buffer
DRUGpH 5.0
DRUGcontaining 4.1% sorbitol in a single-use glass vial.
Sponsors
Apellis Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Evaluate the efficacy of pegcetacoplan in terms of change from baseline in log-transformed urine protein to creatinine ratio (uPCR) Phase 3: Change from baseline in log-transformed urine protein to creatinine ratio (uPCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: Evaluate the efficacy of pegcetacoplan in terms of change from baseline in log-transformed urine albumin to creatinine ratio (uACR) Phase 3: Change from Baseline in log-transformed urine protein to creatinine ratio (uPCR); Proportion of participants achieving Complete Remission; Slope of estimated Glomerular Filtration Rate (eGFR) | — |
Outcome results
None listed