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Trial record 1 of 1 for:    NCT03493685
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Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) (DUPLEX)

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ClinicalTrials.gov Identifier: NCT03493685
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Retrophin, Inc.

Tracking Information
First Submitted Date  ICMJE April 3, 2018
First Posted Date  ICMJE April 10, 2018
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE March 29, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Slope of estimated glomerular filtration rate (eGFR) [ Time Frame: Week 6 to Week 108 ]
    The slope of estimated glomerular filtration rate (eGFR) from Week 6 to Week 108.
  • Proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Slope of estimated glomerular filtration rate (eGFR) [ Time Frame: Week 6 to Week 108 ]
    The slope of estimated glomerular filtration rate (eGFR) from Week 6 to Week 108.
  • Proportion of patients achieving a Up/C ≤1.5 g/g and a >40% [ Time Frame: 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Percentage Change in eGFR [ Time Frame: Week 108 ]
    Percentage change from 6 weeks post randomization at Week 108
  • Percentage Change in eGFR from baseline [ Time Frame: Week 112 ]
    Percentage change in eGFR from baseline to 4 weeks post-cessation of treatment at Week 112
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Percentage Change in eGFR [ Time Frame: Week 108 ]
    Percentage change from 6 weeks post randomization at Week 108
  • Percentage Change in Urine protein/creatinine (Up/C) ratio [ Time Frame: Week 36 ]
    Percentage change in Up/C from baseline at Week 36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
Official Title  ICMJE 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
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).
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 240 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis
Intervention  ICMJE
  • Drug: sparsentan
    target dose of 800 mg daily
    Other Name: RE-021
  • Drug: irbesartan
    target dose of 300 mg daily
    Other Name: Irbesartan Tablets USP
Study Arms  ICMJE
  • 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
    Intervention: Drug: sparsentan
  • 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
    Intervention: Drug: irbesartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Retrophin Call Center 1-877-659-5518 medinfo@retrophin.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Germany,   Hong Kong,   Hungary,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Portugal,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03493685
Other Study ID Numbers  ICMJE 021FSGS16010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Retrophin, Inc.
Study Sponsor  ICMJE Retrophin, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Radko Komers, MD, PhD Retrophin, Inc.
PRS Account Retrophin, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP