AzTrials
AzTrials

Focal Segmental GlomerulosclerosisPhase 3DUPLEXNCT03493685

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

A Phase 3 study testing sparsentan and Irbesartan in people with Focal Segmental Glomerulosclerosis, run by Travere Therapeutics, Inc. at 226 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 8 to 75 years
Conditions the study is for
Focal Segmental Glomerulosclerosis
What is being tested?
sparsentan and Irbesartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
371 participants
Where
226 sitesin 22 countries
Study dates
17 Apr 2018to 19 Mar 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

226 sites in 22 countries.

226 sites in 22 countries

United States87 sites

  • Travere Investigational Site

    Ann Arbor, Michigan, 48109

  • Travere Investigational Site

    Bethlehem, Pennsylvania, 18017

  • Travere Investigational Site

    Boston, Massachusetts, 02111

  • Travere Investigational Site

    Camp Hill, Pennsylvania, 17011

  • Travere Investigational Site

    Chapel Hill, North Carolina, 27514

  • Travere Investigational Site

    Chicago, Illinois, 60611

  • Travere Investigational Site

    Cleveland, Ohio, 44195

  • Travere Investigational Site

    Columbia, South Carolina, 29203

  • Travere Investigational Site

    Columbus, Ohio, 43210

  • Travere Investigational Site

    Coral Springs, Florida, 33071

  • Travere Investigational Site

    Corpus Christi, Texas, 78412

  • Travere Investigational Site

    Dallas, Texas, 75231

  • Travere Investigational Site

    Dallas, Texas, 75235

  • Travere Investigational Site

    Dallas, Texas, 75246

  • Travere Investigational Site

    Denver, Colorado, 80205

  • Travere Investigational Site

    Denver, Colorado, 80230

  • Travere Investigational Site

    Detroit, Michigan, 48202

  • Travere Investigational Site

    Durham, North Carolina, 27710

  • Travere Investigational Site

    El Paso, Texas, 79902

  • Travere Investigational Site

    Fort Lauderdale, Florida, 33308

  • Travere Investigational Site

    Fort Worth, Texas, 76104

  • Travere Investigational Site

    Fresh Meadows, New York, 11365

  • Travere Investigational Site

    Gainesville, Florida, 32610

  • Travere Investigational Site

    Hackensack, New Jersey, 07601

  • Travere Investigational Site

    Hampton, Virginia, 23666

  • Travere Investigational Site

    Hinsdale, Illinois, 60521

  • Travere Investigational Site

    Houston, Texas, 77030

  • Travere Investigational Site

    Houston, Texas, 77054

  • Travere Investigational Site

    Kansas City, Kansas, 66160

  • Travere Investigational Site

    Kansas City, Missouri, 64108

  • Travere Investigational Site

    Kansas City, Missouri, 64111

  • Travere Investigational Site

    Las Vegas, Nevada, 89129

  • Travere Investigational Site

    Lawrenceville, Georgia, 30046

  • Travere Investigational Site

    Lewisville, Texas, 75057

  • Travere Investigational Site

    Los Angeles, California, 90048

  • Travere Investigational Site

    Louisville, Kentucky, 40202

  • Travere Investigational Site

    Marshfield, Wisconsin, 54449

  • Travere Investigational Site

    Memphis, Tennessee, 38103

  • Travere Investigational Site

    Mesa, Arizona, 85210

  • Travere Investigational Site

    Miami, Florida, 33126

  • Travere Investigational Site

    Miami, Florida, 33136

  • Travere Investigational Site

    Miami, Florida, 33155

  • Travere Investigational Site

    Middlebury, Connecticut, 06762

  • Travere Investigational Site

    Minneapolis, Minnesota, 55404

  • Travere Investigational Site

    Minneapolis, Minnesota, 55455

  • Travere Investigational Site

    Monroe, Louisiana, 71201

  • Travere Investigational Site

    Morgantown, West Virginia, 26506

  • Travere Investigational Site

    Nampa, Idaho, 86387

  • Travere Investigational Site

    New Hyde Park, New York, 11040

  • Travere Investigational Site

    New Orleans, Louisiana, 70121

  • Travere Investigational Site

    New York, New York, 10016

  • Travere Investigational Site

    New York, New York, 10029

  • Travere Investigational Site

    New York, New York, 10032

  • Travere Investigational Site

    Northridge, California, 91324

  • Travere Investigational Site

    Ocala, Florida, 34471

  • Travere Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Travere Investigational Site

    Orlando, Florida, 32827

  • Travere Investigational Site

    Palo Alto, California, 94304

  • Travere Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Travere Investigational Site

    Phoenix, Arizona, 85027

  • Travere Investigational Site

    Pittsburgh, Pennsylvania, 15224

  • Travere Investigational Site

    Port Charlotte, Florida, 33952

  • Travere Investigational Site

    Raleigh, North Carolina, 27609

  • Travere Investigational Site

    Reno, Nevada, 89511

  • Travere Investigational Site

    Rochester, Minnesota, 55902

  • Travere Investigational Site

    Roseburg, Oregon, 97471

  • Travere Investigational Site

    Salt Lake City, Utah, 84112

  • Travere Investigational Site

    Salt Lake City, Utah, 84115

  • Travere Investigational Site

    San Diego, California, 92103

  • Travere Investigational Site

    San Dimas, California, 91773

  • Travere Investigational Site

    San Francisco, California, 94118

  • Travere Investigational Site

    Sherman, Texas, 75090

  • Travere Investigational Site

    Shreveport, Louisiana, 71101

  • Travere Investigational Site

    Spokane, Washington, 99204

  • Travere Investigational Site

    Springfield, Massachusetts, 01107

  • Travere Investigational Site

    St. George, Utah, 84790

  • Travere Investigational Site

    Temple Terrace, Florida, 33637

  • Travere Investigational Site

    The Bronx, New York, 10467

  • Travere Investigational Site

    Torrance, California, 90502

  • Travere Investigational Site

    Upland, Pennsylvania, 19013

  • Travere Investigational Site

    Victorville, California, 92395

  • Travere Investigational Site

    Washington D.C., District of Columbia, 20010

  • Travere Investigational Site

    Wauwatosa, Wisconsin, 53226

  • Travere Investigational Site

    Wichita, Kansas, 67214

  • Travere Investigational Site

    Wilmington, Delaware, 19803

  • Travere Investigational Site

    Winston-Salem, North Carolina, 27103

  • Travere Investigational Site

    Winter Park, Florida, 32789

Other trials in United States

Spain20 sites

  • Travere Investigational Site

    Badalona, 8916

  • Travere Investigational Site

    Barcelona, 08003

  • Travere Investigational Site

    Barcelona, 08025

  • Travere Investigational Site

    Barcelona, 08035

  • Travere Investigational Site

    Barcelona, 08036

  • Travere Investigational Site

    Ciudad Real, 13005

  • Travere Investigational Site

    Córdoba, 14004

  • Travere Investigational Site

    Lugo, Burela, 27880

  • Travere Investigational Site

    Madrid, 28040

  • Travere Investigational Site

    Madrid, 28041

  • Travere Investigational Site

    Majadahonda, 28222

  • Travere Investigational Site

    Málaga, 29010

  • Travere Investigational Site

    Palma de Mallorca, Balearic Islands, 07120

  • Travere Investigational Site

    Sagunto, Valencia, 46520

  • Travere Investigational Site

    Santiago de Compostela, 15706

  • Travere Investigational Site

    Seville, 41009

  • Travere Investigational Site

    Seville, 41013

  • Travere Investigational Site

    Valencia, 46014

  • Travere Investigational Site

    Valencia, 46017

  • Travere Investigational Site

    Zaragoza, 50009

Other trials in Spain

United Kingdom15 sites

  • Travere Investigational Site

    Brighton, BN2 5BE

  • Travere Investigational Site

    Cambridge, CB2 0QQ

  • Travere Investigational Site

    Cardiff, CF14 4XW

  • Travere Investigational Site

    Carshalton, London, SM5 1AA

  • Travere Investigational Site

    Fulwood, Preston, PR2 9HT

  • Travere Investigational Site

    Leicester, LE5 4PW

  • Travere Investigational Site

    London, NW3 2QG

  • Travere Investigational Site

    London, SE5 9RS

  • Travere Investigational Site

    Manchester, M13 9WL

  • Travere Investigational Site

    Newcastle, NE7 7DN

  • Travere Investigational Site

    Reading, RG1 5AN

  • Travere Investigational Site

    Salford, M6 8HD

  • Travere Investigational Site

    Swansea, SA6 6NL

  • Travere Investigational Site

    Whitechapel, London, E1 1BB

  • Travere Investigational Site

    York, YO31 8HE

Other trials in United Kingdom

France12 sites

  • Travere Investigational Site

    Bordeaux, 33076

  • Travere Investigational Site

    Clermont-Ferrand, 63003

  • Travere Investigational Site

    Créteil, 94000

  • Travere Investigational Site

    Grenoble, 38043

  • Travere Investigational Site

    Marseille, 13005

  • Travere Investigational Site

    Nice, 06001

  • Travere Investigational Site

    Paris, 75010

  • Travere Investigational Site

    Paris, 75015

  • Travere Investigational Site

    Paris, 75743

  • Travere Investigational Site

    Saint-Priest-en-Jarez, 42270

  • Travere Investigational Site

    Toulouse, 31059

  • Travere Investigational Site

    Valenciennes, 59322

Other trials in France

Italy12 sites

  • Travere Investigational Site

    Bari, 70124

  • Travere Investigational Site

    Bergamo, 24127

  • Travere Investigational Site

    Bologna, 40138

  • Travere Investigational Site

    Florence, 50134

  • Travere Investigational Site

    Genova, 16132

  • Travere Investigational Site

    Germaneto, 88100

  • Travere Investigational Site

    Lecco, 23900

  • Travere Investigational Site

    Milan, 20122

  • Travere Investigational Site

    Monza, 20900

  • Travere Investigational Site

    Pavia, 27100

  • Travere Investigational Site

    Roma, 168

  • Travere Investigational Site

    Verona, 37126

Other trials in Italy

Taiwan10 sites

  • Travere Investigational Site

    Hualien City, 970

  • Travere Investigational Site

    Kaohsiung City, 81362

  • Travere Investigational Site

    New Taipei City, 235

  • Travere Investigational Site

    Taichung, 404

  • Travere Investigational Site

    Taichung, 40705

  • Travere Investigational Site

    Tainan, 710

  • Travere Investigational Site

    Taipei, 10048

  • Travere Investigational Site

    Taipei, 104

  • Travere Investigational Site

    Taipei, 110

  • Travere Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Australia9 sites

  • Travere Investigational Site

    Adelaide, South Australia, 5000

  • Travere Investigational Site

    Birtinya, Queensland, 4575

  • Travere Investigational Site

    Concord, New South Wales, 2139

  • Travere Investigational Site

    Nedlands, Western Australia, 6009

  • Travere Investigational Site

    New Lambton Heights, New South Wales, 2305

  • Travere Investigational Site

    Parkville, Victoria, 3050

  • Travere Investigational Site

    Saint Leonards, New South Wales, 2065

  • Travere Investigational Site

    Wollongong, New South Wales, 2522

  • Travere Investigational Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil8 sites

  • Travere Investigational Site

    Botucatu, 18618-686

  • Travere Investigational Site

    Itaquera, 08270-120

  • Travere Investigational Site

    Passo Fundo, 99010-080

  • Travere Investigational Site

    Porto Alegre, 90035-903

  • Travere Investigational Site

    Recife, 50670-901

  • Travere Investigational Site

    Rio de Janeiro, 20551-030

  • Travere Investigational Site

    São Paulo, 04038-002

  • Travere Investigational Site

    São Paulo, 05403-000

Other trials in Brazil

Portugal8 sites

  • Travere Investigational Site

    Amadora, 2720-276

  • Travere Investigational Site

    Carnaxide, 2790-134

  • Travere Investigational Site

    Lisbon, 1050-099

  • Travere Investigational Site

    Lisbon, 1649-035

  • Travere Investigational Site

    Loures, 2674-514

  • Travere Investigational Site

    Porto, 4200-319

  • Travere Investigational Site

    Setúbal, 2910-446

  • Travere Investigational Site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Germany7 sites

  • Travere Investigational Site

    Aachen, 52074

  • Travere Investigational Site

    Berlin, 10117

  • Travere Investigational Site

    Berlin, 12203

  • Travere Investigational Site

    Düsseldorf, Westfalen, 40210

  • Travere Investigational Site

    Hanover, 30625

  • Travere Investigational Site

    Stuttgart, 70376

  • Travere Investigational Site

    Villingen-Schwenningen, 78052

Other trials in Germany

Poland7 sites

  • Travere Investigational Site

    Lodz, 93-347

  • Travere Investigational Site

    Olsztyn, 10-117

  • Travere Investigational Site

    Olsztyn, 10-561

  • Travere Investigational Site

    Piotrkow Trybunalski, 97-300

  • Travere Investigational Site

    Warsaw, 00-631

  • Travere Investigational Site

    Warsaw, 04-749

  • Travere Investigational Site

    Wroclaw, 50-556

Other trials in Poland

South Korea6 sites

  • Travere Investigational Site

    Busan, 47392

  • Travere Investigational Site

    Daejeon, 35015

  • Travere Investigational Site

    Gyeonggi-do, 13620

  • Travere Investigational Site

    Gyeonggi-do, 14068

  • Travere Investigational Site

    Seoul, 3080

  • Travere Investigational Site

    Seoul, 3722

Other trials in South Korea

Argentina4 sites

  • Travere Investigational Site

    Buenos Aires, C1280AEB

  • Travere Investigational Site

    Córdoba, X5000JHGQ

  • Travere Investigational Site

    Córdoba, X5016LIG

  • Travere Investigational Site

    Santa Fe, S3000

Other trials in Argentina

Belgium3 sites

  • Travere Investigational Site

    Leuven, 3000

  • Travere Investigational Site

    Liège, 4000

  • Travere Investigational Site

    Roeselare, 8800

Other trials in Belgium

Canada3 sites

  • Travere Investigational Site

    Edmonton, Alberta, T6G 2B7

  • Travere Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • Travere Investigational Site

    London, Ontario, N6A 5A5

Other trials in Canada

Czechia3 sites

  • Travere Investigational Site

    Nový Jičín, 74101

  • Travere Investigational Site

    Prague, Prague, 100 34

  • Travere Investigational Site

    Prague, Prague, 120 00

Other trials in Czechia

Sweden3 sites

  • Travere Investigational Site

    Solna, SE-171 64

  • Travere Investigational Site

    Uppsala, 75237

  • Travere Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Denmark2 sites

  • Travere Investigational Site

    Aarhus, Central Jutland, 8200

  • Travere Investigational Site

    Kolding, Southern Denmark, 6000

Other trials in Denmark

Estonia2 sites

  • Travere Investigational Site

    Tallinn, 10617

  • Travere Investigational Site

    Tartu, 50406

Other trials in Estonia

Hong Kong2 sites

  • Travere Investigational Site

    Hong Kong

  • Travere Investigational Site

    Lai Chi Kok

Other trials in Hong Kong

New Zealand2 sites

  • Travere Investigational Site

    Auckland, 1051

  • Travere Investigational Site

    Hamilton, 3204

Other trials in New Zealand

Croatia1 site

  • Travere Investigational Site

    Zagreb, 10000

Other trials in Croatia

About this study

Official 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

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).

Read the detailed description

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.

Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.

Being tested
sparsentan, Irbesartan
Medical subject headings
Glomerulosclerosis, Focal Segmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sparsentanDrug

    Also called RE-021

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

  • IrbesartanDrug

    Also called Irbesartan Tablets USP

    target dose of 300 mg daily

Study groups in NCT03493685
Study groupRoleWhat they receive
sparsentan for double-blind and open-label extensionExperimentalSparsentan 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
Receives: Drug: sparsentan
IrbesartanActive comparatorIrbesartan 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
Receives: Drug: Irbesartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Slope of Estimated Glomerular Filtration Rate (eGFR)

    The total eGFR slope over 2 years, defined as the slope of eGFR following initiation of randomized treatment (ie, Day 1 to Week 108). Estimates are calculated from a mixed-effects model with treatment, Baseline eGFR, analysis visit, treatment-by-analysis visit, randomization stratification factors as fixed effects, and intercept and slope for each participant as a random effect.

    Measured: From Day 1 to Week 108

  2. Percentage of Participants Achieving FSGS Partial Remission Endpoint (FPRE)

    Percentage of participants achieving FPRE, defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 grams/gram (g/g) (170 milligrams per millimoles [mg/mmol]) and a >40% reduction from Baseline was analyzed using a generalized linear model to model probability of achieving FPRE. Missing responses were imputed prior to analysis using multiple imputation. A generalized linear model with appropriate link function was implemented with Baseline log (UP/C), treatment, analysis visit, treatment by analysis visit interaction, and randomization strata as fixed effects. For estimates of probability of achieving FPRE, risk difference, and odds ratio, binomial distribution with logit link was used. For relative risk, Poisson distribution with log link was used. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates for probabilities.

    Measured: Week 36

Secondary outcomes (2)

  1. Slope of eGFR Following the Initial Acute Effect of Randomized Treatment

    The chronic eGFR slope over 2 years, defined as the slope of eGFR following the initial acute effect of randomized treatment (ie, Week 6 to Week 108). Estimates were calculated from a mixed-effects model with linear spline (ie, change point at Week 6), which included treatment, Baseline eGFR, time from Baseline (TFB) (weeks), time from change point (TFCP) (weeks), treatment-by-TFB and treatment-by-TFCP interactions, and randomization stratification factors as fixed effects, intercept and slopes as random effects. The slope difference was tested by the null hypothesis that the sum of the treatment-by-TFB and treatment-by-TFCP interactions = 0.

    Measured: From Week 6 to Week 108

  2. Change From Baseline in eGFR to 4 Weeks Post-cessation of Randomized Treatment

    The change from Baseline to 4 weeks post-cessation of randomized treatment (Week 112) was analyzed via an analysis of covariance (ANCOVA) model on the natural log(eGFR) with treatment, Baseline eGFR, and randomization strata as fixed effects. Only participants who completed the 108-week treatment period were included. Estimated LS Mean and 95% CI are converted to percentages as follows: [exponential (LS mean change from baseline in natural log(eGFR)) minus 1] multiplied by 100. Baseline (Day 1) was defined as the last non-missing assessment prior to and including the first administration of study medication in the study including unscheduled assessments. Percent change from Baseline was calculated as "[(Post Baseline minus Baseline value)/ Baseline value] multiplied by 100.

    Measured: Baseline (Day 1) to Week 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start17 Apr 2018
  3. Primary completion20 Mar 2023
  4. Study completion19 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493685
Sponsor's protocol ID
021FSGS16010
Acronym
DUPLEX
Status last verified
Apr 2026
First submitted
3 Apr 2018
Last updated
17 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Yee J, Gong W, Inrig J, Rheault MN, Gruber AJ, Bedard PW, Komers R, Trachtman H. Antiproteinuric Effect of Sparsentan in Patients with Genetic-Associated FSGS Enrolled in the DUPLEX Trial. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):605-614. doi: 10.2215/CJN.0000000948. Epub 2025 Dec 23.

    PubMed 41433094

  • Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.

    PubMed 40938675

  • Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.

    PubMed 40337980

  • Rheault MN, Alpers CE, Barratt J, Bieler S, Canetta P, Chae DW, Coppock G, Diva U, Gesualdo L, Heerspink HJL, Inrig JK, Kirsztajn GM, Kohan D, Komers R, Kooienga LA, Lieberman K, Mercer A, Noronha IL, Perkovic V, Radhakrishnan J, Rote W, Rovin B, Tesar V, Trimarchi H, Tumlin J, Wong MG, Trachtman H; DUPRO Steering Committee and DUPLEX Investigators. Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis. N Engl J Med. 2023 Dec 28;389(26):2436-2445. doi: 10.1056/NEJMoa2308550. Epub 2023 Nov 3.

    PubMed 37921461

  • Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.

    PubMed 37254256

  • Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sparsentan and Irbesartan in people with Focal Segmental Glomerulosclerosis, run by Travere Therapeutics, Inc. at 226 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Spain, United Kingdom, France, Italy and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Slope of Estimated Glomerular Filtration Rate (eGFR) (time frame: From Day 1 to Week 108). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03493685, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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DUPLEX Clinical Trial NCT03493685 | AzTrials