To evaluate the safety and efficacy of sparsentan tablets for the treatment of patients with proteinuria after kidney transplantation with once-daily dosing for 36 weeks.
This is a 46-week, open-label, multicenter, single-group Phase 4 study to determine the safety and efficacy of sparsentan for the treatment of patients post kidney transplantation with IgAN or FSGS with proteinuria (≥ 0.5 g/g). Eligible participants with a kidney transplant receiving stable standard of care (SOC) therapy, including standard immunosuppressive therapy (IST) to prevent graft rejection, will be enrolled to receive sparsentan treatment for 36 weeks. Participants will remain on standard IST for the duration of the study and will stop RAASi prior to initiating sparsentan treatment. The final dose of a RAASi should be taken on the day before the Day 1 visit. Participants with a kidney transplant, at least one year prior to screening, with biopsy-proven IgAN will take 200 mg orally once daily (QD) for 2 weeks, then 400 mg QD through Week 36. Participants with a kidney transplant with FSGS histological pattern in the graft, or a biopsy finding of both IgAN and glomeruli with FSGS patterns will take 400 mg orally QD for 2 weeks, then 800 mg QD through Week 36. Study visits will be conducted at Day 5 and Weeks 2, 4, 6, 12, 24, and 36 following Day 1. Following the 36 week treatment period, all participants will complete a 4 week off-sparsentan treatment follow-up period (ie, no study drug), during which time treatment will be at the discretion of the investigator. Participants will have a telephone visit at Week 40.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
For participants with a kidney transplant with IgAN: Day 1 through Week 2 visit, participants will take 200 mg once daily (QD) prior to the morning meal. At the Week 2 visit, participants will titrate up to 400 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator. For participants with a kidney transplant with FSGS, or a biopsy finding of both IgAN and glomeruli with FSGS patterns: Day 1 through Week 2 visit, participants will take 400 mg QD prior to the morning meal. At the Week 2 visit, participants will titrate up to 800 mg QD and take this dose through Week 36, if tolerated and determined to be safe by the Investigator.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGCornell Medical Center
New York, New York, United States
RECRUITINGUrinary protein/creatinine ratio (UPCR)
Change from baseline (Day 1) in urinary protein/creatinine ratio (UPCR) to Week 36.
Time frame: 36 weeks
Change from baseline in UPCR
Change from baseline in UPCR each visit.
Time frame: 36 weeks
Urinary albumin/creatinine ratio (UACR)
Change from baseline in UACR at each visit
Time frame: 36 weeks
Change from baseline in eGFR (estimated glomerular filtration rate)
Change from baseline in eGFR, applying creatinine and cystatin C based formulae, at each visit
Time frame: 36 weeks
Change from baseline in blood pressure (BP)
Change in systolic and diastolic BP at each visit
Time frame: 36 weeks
Achievement of UPCR <0.3 g/g
Achievement of UPCR \<0.3 g/g at Weeks 12, 24 and 36
Time frame: 36 weeks
30% and 50% reductions in UPCR
The proportion of participants achieving 30% and 50% reductions in UPCR at Week 36.
Time frame: 36 weeks
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University of North Carolina Chapel Hill
Morrisville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGDallas Nephrology Associates
Dallas, Texas, United States
RECRUITINGUniversity of Texas
Galveston, Texas, United States
RECRUITINGUniversity of Washington
Seattle, Washington, United States
RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
RECRUITING