A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

Conditions

Focal segmental glomerulosclerosis (FSGS)

Brief summary

Efficacy End points: The primary efficacy endpoint is the slope of eGFR over approximately 2 years of randomized treatment assessed at the final analysis. The surrogate efficacy endpoint is the proportion of patients achieving a target reduction in proteinuria., Safety End points: Descriptive statistics will be used to summarize the safety data., Open-Label Endpoints: Endpoints for the open-label extension include, but are not necessarily limited to : The absolute and percent change from Week 112 in eGFR at each visit, Open-Label Endpoints: The percent change from Week 112 in UP/C at each visit, Open-Label Endpoints: Changes from Week 112 in QOL at each visit, Open-Label Endpoints: Changes from Week 112 in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters, Open-Label Endpoints: Changes from Week 112 in lipid profile (total cholesterol and triglycerides, LDL-C, and HDL C, Open-Label Endpoints: The incidence of TEAEs during the open-label extension

Detailed description

Secondary Efficacy Endpoints: The secondary efficacy endpoints in non-US countries are: • The percent change from Week 6 in eGFR at Week 108 • The percent change in eGFR from baseline of the double-blind period to 4 weeks post -cessation of randomized treatment at Week 112 • The slope of eGFR following the initiation of randomized treatment

Related papers

No related papers found yet.

Interventions

DRUGIRBESARTAN

DRUGSparsentan_DF3

DRUGSparsentan_DF2

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy End points: The primary efficacy endpoint is the slope of eGFR over approximately 2 years of randomized treatment assessed at the final analysis. The surrogate efficacy endpoint is the proportion of patients achieving a target reduction in proteinuria., Safety End points: Descriptive statistics will be used to summarize the safety data., Open-Label Endpoints: Endpoints for the open-label extension include, but are not necessarily limited to : The absolute and percent change from Week 112 in eGFR at each visit, Open-Label Endpoints: The percent change from Week 112 in UP/C at each visit, Open-Label Endpoints: Changes from Week 112 in QOL at each visit, Open-Label Endpoints: Changes from Week 112 in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters, Open-Label Endpoints: Changes from Week 112 in lipid profile (total cholesterol and triglycerides, LDL-C, and HDL C, Open-Label Endpoints: The incidence of TEAEs during the open-la	—

Measure

Time frame

Efficacy End points: The primary efficacy endpoint is the slope of eGFR over approximately 2 years of randomized treatment assessed at the final analysis. The surrogate efficacy endpoint is the proportion of patients achieving a target reduction in proteinuria., Safety End points: Descriptive statistics will be used to summarize the safety data., Open-Label Endpoints: Endpoints for the open-label extension include, but are not necessarily limited to : The absolute and percent change from Week 112 in eGFR at each visit, Open-Label Endpoints: The percent change from Week 112 in UP/C at each visit, Open-Label Endpoints: Changes from Week 112 in QOL at each visit, Open-Label Endpoints: Changes from Week 112 in body weight, vital signs, physical examinations, peripheral edema, and clinical laboratory parameters, Open-Label Endpoints: Changes from Week 112 in lipid profile (total cholesterol and triglycerides, LDL-C, and HDL C, Open-Label Endpoints: The incidence of TEAEs during the open-la

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Secondary

Measure	Time frame
Secondary Efficacy Endpoints: The secondary efficacy endpoints in non-US countries are: • The percent change from Week 6 in eGFR at Week 108 • The percent change in eGFR from baseline of the double-blind period to 4 weeks post -cessation of randomized treatment at Week 112 • The slope of eGFR following the initiation of randomized treatment	—

Countries

Belgium, Croatia, Czechia, Denmark, Estonia, France, Germany, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed