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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 : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Retrophin, Inc.

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 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).


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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


Arm Intervention/treatment
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
Drug: sparsentan
target dose of 800 mg 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




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



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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:

  • 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.

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


Contacts
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Contact: Retrophin Call Center 1-877-659-5518 medinfo@retrophin.com

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Sponsors and Collaborators
Retrophin, Inc.
Investigators
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Study Director: Radko Komers, MD, PhD Retrophin, Inc.

Additional Information:
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Responsible Party: Retrophin, Inc.
ClinicalTrials.gov Identifier: NCT03493685     History of Changes
Other Study ID Numbers: 021FSGS16010
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Irbesartan
Angiotensin Receptor Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action