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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03493685
Ethics application status
Date submitted
3/04/2018
Date registered
10/04/2018
Date last updated
15/05/2020

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 - 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

Active Comparator: irbesartan - 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


Treatment: Drugs: sparsentan
target dose of 800 mg 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) - The slope of estimated glomerular filtration rate (eGFR) from Week 6 to Week 108.
Timepoint [1] 0 0
Week 6 to Week 108
Primary outcome [2] 0 0
Proportion of patients achieving a UP/C =1.5 g/g and a >40% reduction - Proportion of patients achieving a UP/C =1.5 g/g and a >40% reduction from baseline in UP/C at Week 36
Timepoint [2] 0 0
Week 36
Secondary outcome [1] 0 0
Percentage Change in eGFR - Percentage change from 6 weeks post randomization at Week 108
Timepoint [1] 0 0
Week 108
Secondary outcome [2] 0 0
Percentage Change in eGFR from baseline - Percentage change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112
Timepoint [2] 0 0
Week 112

Eligibility
Key inclusion criteria
Key

- 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) or documentation of a genetic
mutation in a podocyte protein associated with FSGS

- Urine protein/creatinine (UP/C) =1.5 g/g at screening

- eGFR =30 mL/min/1.73 m2 at screening.

- Women of childbearing potential (WOCBP) 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

- 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 (HIV) or markers indicating
acute or chronic hepatitis B 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% or hemoglobin value <9 g/dL

- Screening potassium value of >5.5 mEq/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.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Retrophin Investigational Site - Concord
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Retrophin Investigational Site - New Lambton
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Retrophin Investigational Site - Saint Leonards
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Retrophin Investigational Site - Wollongong
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Retrophin Investigational Site - Birtinya
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Retrophin Investigational Site - Woolloongabba
Recruitment hospital [7] 0 0
Retrophin Investigational Site - Adelaide
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Retrophin Investigational Site - Parkville
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Retrophin Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
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
Retrophin, 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/show/NCT03493685
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radko Komers, MD, PhD
Address 0 0
Retrophin, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Retrophin Call Center
Address 0 0
Country 0 0
Phone 0 0
1-877-659-5518
Fax 0 0
Email 0 0
medinfo@retrophin.com
Contact person for scientific queries

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