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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03493685




Registration number
NCT03493685
Ethics application status
Date submitted
3/04/2018
Date registered
10/04/2018
Date last updated
30/04/2024

Titles & IDs
Public title
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
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
Secondary ID [1] 0 0
021FSGS16010
Universal Trial Number (UTN)
Trial acronym
DUPLEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Segmental Glomerulosclerosis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - sparsentan
Treatment: Drugs - Irbesartan

Experimental: sparsentan for double-blind and open-label extension - Sparsentan will be administered as a single oral dose; an initial dose of 400 mg daily titrating up to a target dose of 800 mg, daily

Active Comparator: Irbesartan - Irbesartan will be administered as a single oral dose; an initial dose of 150 mg daily titrating up to a target dose of 300 mg, daily


Treatment: Drugs: sparsentan
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily

Treatment: Drugs: Irbesartan
target dose of 300 mg daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Slope of Estimated Glomerular Filtration Rate (eGFR)
Timepoint [1] 0 0
From Day 1 to Week 108
Primary outcome [2] 0 0
Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)
Timepoint [2] 0 0
Week 36
Secondary outcome [1] 0 0
Slope of eGFR Following the Initial Acute Effect of Randomized Treatment
Timepoint [1] 0 0
From Week 6 to Week 108
Secondary outcome [2] 0 0
Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment
Timepoint [2] 0 0
Baseline (Day 1) to Week 112

Eligibility
Key inclusion 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
Minimum age
8 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
Accrual to date
Final
371
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Travere Investigational Site - Concord
Recruitment hospital [2] 0 0
Travere Investigational Site - New Lambton Heights
Recruitment hospital [3] 0 0
Travere Investigational Site - Saint Leonards
Recruitment hospital [4] 0 0
Travere Investigational Site - Wollongong
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Travere Investigational Site - Birtinya
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Travere Investigational Site - Woolloongabba
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Travere Investigational Site - Adelaide
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Travere Investigational Site - Parkville
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Travere Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
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2305 - New Lambton Heights
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2065 - Saint Leonards
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2522 - Wollongong
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4575 - Birtinya
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4102 - Woolloongabba
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5000 - Adelaide
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3050 - Parkville
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Travere Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03493685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Priscila Preciado, MD
Address 0 0
Travere Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03493685