Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03493685
• Date of registration: 03/04/2018
• Prospective Registration: Yes
• Primary sponsor: Travere Therapeutics, Inc.
• Public title: Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) DUPLEX
• Scientific 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
• Date of first enrolment: April 17, 2018
• Target sample size: 371
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03493685
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, New Zealand, Poland, Portugal, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: Priscila Preciado, MD
• Affiliation: Travere Therapeutics, Inc.

Key inclusion & exclusion criteria

Key Inclusion Criteria for the Double-blind Period:

- Sites within the US and UK: The patient is male or female aged 8 to 75 years,
inclusive, weighing =20 kg at screening

- Sites outside the US and UK: 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

Key Exclusion Criteria 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



Age minimum: 8 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: Irbesartan

Drug: sparsentan

Primary Outcome(s)

Slope of Estimated Glomerular Filtration Rate (eGFR) [Time Frame: From Day 1 to Week 108]

Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE) [Time Frame: Week 36]

Secondary Outcome(s)

Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment [Time Frame: Baseline (Day 1) to Week 112]

Slope of eGFR Following the Initial Acute Effect of Randomized Treatment [Time Frame: From Week 6 to Week 108]

Secondary ID(s)

021FSGS16010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/04/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03493685