Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX)
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|ClinicalTrials.gov Identifier: NCT03493685|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2018
Last Update Posted : October 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Focal Segmental Glomerulosclerosis||Drug: sparsentan Drug: Irbesartan||Phase 3|
This is a randomized, multicenter, double-blind, parallel, active-control study. Approximately 300 patients aged 8 to 75 years (inclusive) will be enrolled in the study. The study will be conducted in approximately 300 study centers, globally. The investigational drug (sparsentan) is a dual-acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. Patients who meet eligibility criteria will require washout from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug.
Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
After completing the double-blind portion of the study, patients may participate in the open-label extension for treatment with sparsentan if they meet eligibility criteria.
Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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 FSGS|
|Actual Study Start Date :||April 17, 2018|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2026|
Experimental: sparsentan for double-blind and open-label extension
Sparsentan will be administered as a single oral morning dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Other Name: RE-021
Active Comparator: Irbesartan
Irbesartan will be administered as a single oral morning dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily
target dose of 300 mg daily
Other Name: Irbesartan Tablets USP
- Slope of estimated glomerular filtration rate (eGFR) [ Time Frame: Week 108 ]The slope of eGFR from Day 1 to Week 108. (Secondary outcome measure in non-US countries)
- Proportion of patients achieving a urine protein/creatinine (UP/C) ≤1.5 g/g and a >40% reduction [ Time Frame: Week 36 ]Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction from baseline in UP/C at Week 36
- Slope of eGFR [ Time Frame: Week 6 to Week 108 ]The slope of eGFR from 6 weeks post randomization at Week 108. (Primary outcome in non-US countries)
- Change in eGFR from baseline [ Time Frame: Week 112 ]Change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112. (Percent change in eGFR in non-US countries)
- Non-US countries: Percent change in eGFR [ Time Frame: Week 6 to Week 108 ]Percent change from Week 6 in eGFR at Week 108
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493685
|Study Director:||Priscila Preciado, MD||Travere Therapeutics, Inc.|