Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).
- Focal Segmental Glomerulosclerosis
- Eligible Ages
- Between 8 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
for the Double-blind Period: - Sites within the US: The patient is male or female aged 8 to 75 years, inclusive, weighing ≥20 kg at screening - Sites outside the US: The patient is male or female aged 18 to 75 years, inclusive, weighing ≥20 kg at screening - Biopsy-proven focal segmental glomerulosclerosis (FSGS) lesion(s) or documentation of a genetic mutation in a podocyte protein associated with FSGS. - Urine protein/creatinine (UP/C) ≥1.5 g/g (170 mg/mmol) at screening - eGFR ≥30 mL/min/1.73 m2 at screening. - Women of childbearing potential must agree to the use of one highly reliable method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication, plus one additional barrier method during sexual activity
for the Double-blind Period: - FSGS secondary to another condition - Positive serological tests of another primary or secondary glomerular disease not consistent with a diagnosis of primary or genetic FSGS - History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus, or nonfasting blood glucose >180 mg/dL (10.0 mmol/L) - Treated with rituximab, cyclophosphamide, or abatacept within ≤3 months prior to screening; if taking other chronic immunosuppressive medications, the dosage must be stable prior to screening - Documented history of heart failure, coronary artery disease, or cerebrovascular disease - Significant liver disease - Positive at screening for the human immunodeficiency virus or markers indicating acute or chronic hepatitis B virus infection or hepatitis C infection - History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years - Screening hematocrit value <27% (0.27 L/L) or hemoglobin value <9 g/dL (90 g/L) - Screening potassium value of >5.5 mEq/L (5.5 mmol/L) - Extreme obesity (ie, ≥18 years of age with a body mass index (BMI) >40, or is <18 years of age with a BMI in the 99th percentile plus 5 units at screening, in whom there is a causal relationship between obesity and the development of FSGS - History of alcohol or illicit drug use disorder - History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist - Female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. Key Inclusion Criteria for the Open-label Extension Based on assessments at the Week 108 visit: - Complete participation in the double-blind period, including the Week 112 visit. - Patient received blinded study medication through the duration of the double-blind period (ie, did not permanently discontinue study medication) Key Exclusion Criteria for the Open-label Extension Based on Assessments at Week 108 and 112 visits: - Progression to end-stage renal disease requiring replacement therapy - The patient developed criteria for discontinuation between Week 108 and Week 112 - The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 108 and Week 112 - eGFR ≤20 mL/min/1.73 m2 at Week 108
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
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||
|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||
- NCT ID
- Active, not recruiting
- Travere Therapeutics, Inc.
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.