Focal segmental glomerulosclerosis
Conditions
Brief summary
Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104
Detailed description
Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104, Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104, Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint), Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104, Change from baseline across disease-specific COA NS-SIM-PRO at Week 104, Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104
Interventions
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in 24-hour urinary protein-to-creatinine ratio (UPCR, measured in mg/g) from baseline to Week 104 | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: Absolute change in eGFRcys in mL/min/1.73m2 from baseline to Week 104, Key secondary endpoint: Treatment response, defined as 24-hr UPCR <1000 mg/g at Week 104, Treatment response, defined as 24-hr UPCR <1000 mg/g and eGFRcys ≥85% vs. baseline at Week 104 and no treatment failure between randomisation and Week 104 (combined or multi-component endpoint), Complete remission, defined as 24-hr UPCR <300 mg/g at Week 104, Change from baseline across disease-specific COA NS-SIM-PRO at Week 104, Change from baseline across Clinical Outcome Assessment (COA) KDQOL-36 at Week 104 | — |
Outcome results
None listed