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

Sponsor
Travere Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03493685
Collaborator
(none)
371
Enrollment
225
Locations
2
Arms
94.2
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
371 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 29, 2018
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: sparsentan for double-blind and open-label extension

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

Drug: sparsentan
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Other Names:
  • RE-021

    		•
    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

    Drug: Irbesartan
    target dose of 300 mg daily
    Other Names:
  • Irbesartan Tablets USP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Slope of estimated glomerular filtration rate (eGFR) [Week 6 to Week 108]

      The slope of estimated glomerular filtration rate (eGFR) from Week 6 to Week 108.

    2. Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction [Week 36]

      Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction from baseline in UP/C at Week 36

    Secondary Outcome Measures

    1. Percentage Change in eGFR [Week 108]

      Percentage change from 6 weeks post randomization at Week 108

    2. Percentage Change in eGFR from baseline [Week 112]

      Percentage change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria for the Double-blind Period:

    • 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) 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Travere Investigational Site Mesa Arizona United States 85210
    2 Travere Investigational Site Phoenix Arizona United States 85027
    3 Travere Investigational Site Los Angeles California United States 90048
    4 Travere Investigational Site Northridge California United States 91324
    5 Travere Investigational Site Palo Alto California United States 94304
    6 Travere Investigational Site San Diego California United States 92103
    7 Travere Investigational Site San Dimas California United States 91773
    8 Travere Investigational Site San Francisco California United States 94118
    9 Travere Investigational Site Torrance California United States 90502
    10 Travere Investigational Site Victorville California United States 92395
    11 Travere Investigational Site Denver Colorado United States 80205
    12 Travere Investigational Site Denver Colorado United States 80230
    13 Travere Investigational Site Middlebury Connecticut United States 06762
    14 Travere Investigational Site Wilmington Delaware United States 19803
    15 Travere Investigational Site Washington District of Columbia United States 20010
    16 Travere Investigational Site Coral Springs Florida United States 33071
    17 Travere Investigational Site Fort Lauderdale Florida United States 33308
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    19 Travere Investigational Site Miami Florida United States 33126
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    187 Travere Investigational Site Córdoba Spain 14004
    188 Travere Investigational Site Madrid Spain 28040
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    190 Travere Investigational Site Majadahonda Spain 28222
    191 Travere Investigational Site Málaga Spain 29010
    192 Travere Investigational Site Santiago De Compostela Spain 15706
    193 Travere Investigational Site Sevilla Spain 41009
    194 Travere Investigational Site Sevilla Spain 41013
    195 Travere Investigational Site Valencia Spain 46014
    196 Travere Investigational Site Valencia Spain 46017
    197 Travere Investigational Site Zaragoza Spain 50009
    198 Travere Investigational Site Solna Sweden SE-171 64
    199 Travere Investigational Site Uppsala Sweden 75237
    200 Travere Investigational Site Uppsala Sweden SE-751 85
    201 Travere Investigational Site Hualien City Taiwan 970
    202 Travere Investigational Site Kaohsiung City Taiwan 81362
    203 Travere Investigational Site New Taipei City Taiwan 235
    204 Travere Investigational Site Taichung Taiwan 404
    205 Travere Investigational Site Taichung Taiwan 40705
    206 Travere Investigational Site Tainan City Taiwan 710
    207 Travere Investigational Site Taipei City Taiwan 104
    208 Travere Investigational Site Taipei City Taiwan 110
    209 Travere Investigational Site Taipei Taiwan 10048
    210 Travere Investigational Site Taoyuan Taiwan 333
    211 Travere Investigational Site Carshalton London United Kingdom SM5 1AA
    212 Travere Investigational Site Whitechapel London United Kingdom E1 1BB
    213 Travere Investigational Site Fulwood Preston United Kingdom PR2 9HT
    214 Travere Investigational Site Brighton United Kingdom BN2 5BE
    215 Travere Investigational Site Cambridge United Kingdom CB2 0QQ
    216 Travere Investigational Site Cardiff United Kingdom CF14 4XW
    217 Travere Investigational Site Leicester United Kingdom LE5 4PW
    218 Travere Investigational Site London United Kingdom NW3 2QG
    219 Travere Investigational Site London United Kingdom SE5 9RS
    220 Travere Investigational Site Manchester United Kingdom M13 9WL
    221 Travere Investigational Site Newcastle United Kingdom NE7 7DN
    222 Travere Investigational Site Reading United Kingdom RG1 5AN
    223 Travere Investigational Site Salford United Kingdom M6 8HD
    224 Travere Investigational Site Swansea United Kingdom SA6 6NL
    225 Travere Investigational Site York United Kingdom YO31 8HE

    Sponsors and Collaborators

    • Travere Therapeutics, Inc.

    Investigators

    • Study Director: Priscila Preciado, MD, Travere Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Travere Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT03493685
    Other Study ID Numbers:
    • 021FSGS16010
    First Posted:
    Apr 10, 2018
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glomerulosclerosis, Focal Segmental
    Irbesartan

    Study Results

    No Results Posted as of Jun 16, 2022