Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03493685
Recruitment Status : Active, not recruiting
First Posted : April 10, 2018
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Travere Therapeutics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Focal Segmental Glomerulosclerosis Drug: sparsentan Drug: Irbesartan 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : March 29, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Irbesartan Tablets USP


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Percentage Change in eGFR [ Time Frame: Week 108 ]
    Percentage change from 6 weeks post randomization at Week 108

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493685


Locations
Show Show 274 study locations
Sponsors and Collaborators
Travere Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Radko Komers, MD, PhD Travere Therapeutics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Travere Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03493685    
Other Study ID Numbers: 021FSGS16010
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
 Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action