A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)
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|ClinicalTrials.gov Identifier: NCT03762850|
Recruitment Status : Recruiting
First Posted : December 4, 2018
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunoglobulin A Nephropathy||Drug: sparsentan Drug: irbesartan||Phase 3|
This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan.
The purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.
Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose.
The primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy|
|Actual Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||April 2023|
Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400 mg and continue treatment to Week 110.
Target dose of 400 mg daily
Other Name: RE-021
Active Comparator: irbesartan
Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.
Target dose of 300 mg daily
Other Name: Irbesartan Tablets USP
- Urine protein/creatinine ratio (UP/C) at Week 36 [ Time Frame: After the last patient randomized has undergone the Week 36 visit ]The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C, based on a 24-hour urine sample, at Week 36.
- eGFR over a 58-week period [ Time Frame: Week 58 post-randomization ]The rate of change in eGFR over a 58-week (approximately 1-year) period following the initiation of randomized therapy (thus, the analysis is from baseline to 58 weeks post randomization eGFR total slope at 1 year)
- eGFR over a 110-week period [ Time Frame: Week 110 post-randomization ]The rate of change in eGFR over a 110-week (approximately 2-year) period following the initiation of randomized therapy (thus, the analysis is from baseline to 110 weeks post randomization eGFR total slope at 2 years).
- eGFR over a 52-week period [ Time Frame: Week 58 post-randomization ]The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks post-randomization to 58 weeks post-randomization eGFR chronic slope at 1 year.)
- eGFR over a 104-week period [ Time Frame: Week 110 post-randomization ]The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks post-randomization to 110 weeks post-randomization eGFR chronic slope at 2 years.)
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): NCT03762850
|Contact: Retrophin Call Centerfirstname.lastname@example.org|
|Study Director:||Radko Komers, MD, PhD||Travere Therapeutics, Inc.|