Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03493685
Ethics application status
Date submitted
3/04/2018
Date registered
10/04/2018

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
Recruitment hospital [5] 0 0
Travere Investigational Site - Birtinya
Recruitment hospital [6] 0 0
Travere Investigational Site - Woolloongabba
Recruitment hospital [7] 0 0
Travere Investigational Site - Adelaide
Recruitment hospital [8] 0 0
Travere Investigational Site - Parkville
Recruitment hospital [9] 0 0
Travere Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
2522 - Wollongong
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Córdoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Belgium
State/province [37] 0 0
Liège
Country [38] 0 0
Belgium
State/province [38] 0 0
Roeselare
Country [39] 0 0
Brazil
State/province [39] 0 0
Botucatu
Country [40] 0 0
Brazil
State/province [40] 0 0
Itaquera
Country [41] 0 0
Brazil
State/province [41] 0 0
Passo Fundo
Country [42] 0 0
Brazil
State/province [42] 0 0
Porto Alegre
Country [43] 0 0
Brazil
State/province [43] 0 0
Recife
Country [44] 0 0
Brazil
State/province [44] 0 0
Rio De Janeiro
Country [45] 0 0
Brazil
State/province [45] 0 0
São Paulo
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Croatia
State/province [49] 0 0
Zagreb
Country [50] 0 0
Czechia
State/province [50] 0 0
Praha
Country [51] 0 0
Czechia
State/province [51] 0 0
Nový Jicín
Country [52] 0 0
Denmark
State/province [52] 0 0
Region Midtjylland
Country [53] 0 0
Denmark
State/province [53] 0 0
Southern Denmark
Country [54] 0 0
Estonia
State/province [54] 0 0
Tallin
Country [55] 0 0
Estonia
State/province [55] 0 0
Tartu
Country [56] 0 0
France
State/province [56] 0 0
Bordeaux
Country [57] 0 0
France
State/province [57] 0 0
Clermont-Ferrand
Country [58] 0 0
France
State/province [58] 0 0
Créteil
Country [59] 0 0
France
State/province [59] 0 0
Grenoble Cedex 9
Country [60] 0 0
France
State/province [60] 0 0
Marseille
Country [61] 0 0
France
State/province [61] 0 0
Nice
Country [62] 0 0
France
State/province [62] 0 0
Paris Cedex 15
Country [63] 0 0
France
State/province [63] 0 0
Paris
Country [64] 0 0
France
State/province [64] 0 0
Saint-Priest-en-Jarez
Country [65] 0 0
France
State/province [65] 0 0
Toulouse
Country [66] 0 0
France
State/province [66] 0 0
Valenciennes
Country [67] 0 0
Germany
State/province [67] 0 0
Westfalen
Country [68] 0 0
Germany
State/province [68] 0 0
Aachen
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
Country [70] 0 0
Germany
State/province [70] 0 0
Hanover
Country [71] 0 0
Germany
State/province [71] 0 0
Stuttgart
Country [72] 0 0
Germany
State/province [72] 0 0
Villingen-Schwenningen
Country [73] 0 0
Hong Kong
State/province [73] 0 0
Hong Kong
Country [74] 0 0
Hong Kong
State/province [74] 0 0
Lai Chi Kok
Country [75] 0 0
Italy
State/province [75] 0 0
Bari
Country [76] 0 0
Italy
State/province [76] 0 0
Bergamo
Country [77] 0 0
Italy
State/province [77] 0 0
Bologna
Country [78] 0 0
Italy
State/province [78] 0 0
Firenze
Country [79] 0 0
Italy
State/province [79] 0 0
Genova
Country [80] 0 0
Italy
State/province [80] 0 0
Germaneto
Country [81] 0 0
Italy
State/province [81] 0 0
Lecco
Country [82] 0 0
Italy
State/province [82] 0 0
Milano
Country [83] 0 0
Italy
State/province [83] 0 0
Monza
Country [84] 0 0
Italy
State/province [84] 0 0
Pavia
Country [85] 0 0
Italy
State/province [85] 0 0
Roma
Country [86] 0 0
Italy
State/province [86] 0 0
Verona
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Busan
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Daejeon
Country [89] 0 0
Korea, Republic of
State/province [89] 0 0
Gyeonggi-do
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Seoul
Country [91] 0 0
New Zealand
State/province [91] 0 0
Auckland
Country [92] 0 0
New Zealand
State/province [92] 0 0
Hamilton
Country [93] 0 0
Poland
State/province [93] 0 0
Olsztyn
Country [94] 0 0
Poland
State/province [94] 0 0
Piotrków Trybunalski
Country [95] 0 0
Poland
State/province [95] 0 0
Warsaw
Country [96] 0 0
Poland
State/province [96] 0 0
Wroclaw
Country [97] 0 0
Poland
State/province [97] 0 0
Lódz
Country [98] 0 0
Portugal
State/province [98] 0 0
Amadora
Country [99] 0 0
Portugal
State/province [99] 0 0
Carnaxide
Country [100] 0 0
Portugal
State/province [100] 0 0
Lisboa
Country [101] 0 0
Portugal
State/province [101] 0 0
Lisbon
Country [102] 0 0
Portugal
State/province [102] 0 0
Loures
Country [103] 0 0
Portugal
State/province [103] 0 0
Porto
Country [104] 0 0
Portugal
State/province [104] 0 0
Setúbal
Country [105] 0 0
Portugal
State/province [105] 0 0
Vila Nova De Gaia
Country [106] 0 0
Spain
State/province [106] 0 0
Baleares
Country [107] 0 0
Spain
State/province [107] 0 0
Burela
Country [108] 0 0
Spain
State/province [108] 0 0
Valencia
Country [109] 0 0
Spain
State/province [109] 0 0
Badalona
Country [110] 0 0
Spain
State/province [110] 0 0
Barcelona
Country [111] 0 0
Spain
State/province [111] 0 0
Ciudad Real
Country [112] 0 0
Spain
State/province [112] 0 0
Córdoba
Country [113] 0 0
Spain
State/province [113] 0 0
Madrid
Country [114] 0 0
Spain
State/province [114] 0 0
Majadahonda
Country [115] 0 0
Spain
State/province [115] 0 0
Málaga
Country [116] 0 0
Spain
State/province [116] 0 0
Santiago De Compostela
Country [117] 0 0
Spain
State/province [117] 0 0
Sevilla
Country [118] 0 0
Spain
State/province [118] 0 0
Zaragoza
Country [119] 0 0
Sweden
State/province [119] 0 0
Solna
Country [120] 0 0
Sweden
State/province [120] 0 0
Uppsala
Country [121] 0 0
Taiwan
State/province [121] 0 0
Hualien City
Country [122] 0 0
Taiwan
State/province [122] 0 0
Kaohsiung City
Country [123] 0 0
Taiwan
State/province [123] 0 0
New Taipei City
Country [124] 0 0
Taiwan
State/province [124] 0 0
Taichung
Country [125] 0 0
Taiwan
State/province [125] 0 0
Tainan City
Country [126] 0 0
Taiwan
State/province [126] 0 0
Taipei City
Country [127] 0 0
Taiwan
State/province [127] 0 0
Taipei
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taoyuan
Country [129] 0 0
United Kingdom
State/province [129] 0 0
London
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Preston
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Brighton
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Cambridge
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Cardiff
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Leicester
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Manchester
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Newcastle
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Reading
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Salford
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Swansea
Country [140] 0 0
United Kingdom
State/province [140] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Travere Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Radko Komers, MD, PhD
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests for clinical trial data, including language stating its intended use, should be directed to datarequest@travere.com. If approved, the requested information will be provided to the requestor after signing a data access agreement. Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication. Travere reserves the right to decline or recommend modifications to a request if it does not comply with the data sharing policy or if it is determined that the request is made by a biased source.
When will data be available (start and end dates)?
Requests can be made following completion of the study and full publication of the study data in a peer reviewed journal for up to 36 months following its publication.
Available to whom?
Requires submission and approval of intended use and a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03493685