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Study of Sparsentan in FSGS (DUPLEX)

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ClinicalTrials.gov Identifier: NCT03493685
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : May 7, 2018
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 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 150 study centers, globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out 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 : 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 Focal Segmental Glomerulosclerosis (FSGS)
Actual Study Start Date : April 3, 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% [ 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 Urine protein/creatinine (Up/C) ratio [ Time Frame: Week 36 ]
    Percentage change in Up/C from baseline at Week 36



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Ages Eligible for Study:   8 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. The patient or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent, and where required, the patient is willing to provide assent, prior to any screening procedures.
  2. The patient has biopsy-proven primary focal segmental glomerulosclerosis (FSGS) or documentation of a genetic mutation in a podocyte protein associated with FSGS.
  3. Sites within the US: The patient is male or female aged 8 to 75 years, inclusive.

    Sites outside the US: The patient is male or female aged 18 to 75 years, inclusive.

  4. The patient has a urine protein/creatinine (Up/C) ≥1.5 g/g at screening.
  5. The patient has an eGFR ≥30 mL/min/1.73 m2 at screening.
  6. Women of childbearing potential (WOCBP) must agree to the simultaneous use of 2 medically accepted methods of contraception from Day 1/Randomization until 90 days after the last dose of study medication.
  7. Males must be surgically sterile (more than 3 months post-vasectomy) or must agree to the use of medically accepted methods of contraception that are considered highly reliable from Day 1/Randomization until 90 days after the last dose of study medication.

Key Exclusion Criteria:

  1. The patient has FSGS secondary to another condition.
  2. The patient has positive serological tests of primary or secondary glomerular injury not consistent with a diagnosis of primary or genetic FSGS.
  3. The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus.
  4. The patient has undergone any organ transplantation, with the exception of corneal transplants, or has received certain immunosupressive medications.
  5. The patient has a documented history of heart failure, coronary artery disease or cerebrovascular disease.
  6. The patient has significant liver disease.
  7. The patient is positive at screening for the human immunodeficiency virus (HIV) or markers indicating acute or chronic hepatitis B infection or hepatitis C infection.
  8. The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
  9. The patient has disqualifying laboratory abnormalities during a screening.
  10. The patient is >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.
  11. The patient has a history of alcohol or illicit drug use disorder.
  12. The patient has a history of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist.
  13. The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
  14. The male patient plans to father a child during the course of the study.
  15. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study medication capsules whole.

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

Locations
United States, Colorado
Colorado Kidney Care Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Nephrology Associates of Central Florida Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
Renal Associates, LLC Recruiting
Columbus, Georgia, United States, 31904
United States, Indiana
Nephrology Specialists, PC Recruiting
Merrillville, Indiana, United States, 46410
United States, Massachusetts
Renal and Transplant Associates of New England, PC Recruiting
Springfield, Massachusetts, United States, 01107
United States, Missouri
Clinical Research Consultants, LLC Recruiting
Kansas City, Missouri, United States, 64111
United States, Nevada
Sierra Nevada Nephrology Consultants Recruiting
Reno, Nevada, United States, 89511
United States, North Carolina
University of North Carolina Kidney Center Recruiting
Chapel Hill, North Carolina, United States, 27514
Brookview Hills Research Associates, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Columbia Nephrology Associates Recruiting
Columbia, South Carolina, United States, 29201
United States, Utah
Southern Utah Kidney and Hypertension Center Recruiting
Saint George, Utah, United States, 84790
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Retrophin, Inc.
Investigators
Study Director: Radko Komers, MD, PhD Retrophin, Inc.

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: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Irbesartan
Angiotensin Receptor Antagonists
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action