Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

Conditions

• Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex

ALL

Age

8 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• RE-021 (Sparsentan) — DRUG
  Oral, once-daily
• Irbesartan — DRUG
  Oral, once-daily

Study Details

This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).

Key Dates

Start date

Mar 31, 2014

Status verified

Apr 2025

Primary completion

Jun 30, 2016

Completion

Mar 25, 2024

Study Design

Enrollment

109 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: RE-021 (Sparsentan) 200 mg - Double-Blind Period
  RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 200mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
• Experimental: RE-021 (Sparsentan) 400 mg - Double-Blind Period
  RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 400mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
• Experimental: RE-021 (Sparsentan) 800 mg - Double-Blind Period
  RE-021 (Sparsentan) will be administered as a single oral morning dose. In this ARM the RE-021 (Sparsentan) dose will be 800mg. Patients at \</= 50kg will receive half of the RE-021 (Sparsentan) dose for the 8 week duration.
• Active Comparator: Irbesartan 300 mg - Double-Blind Period
  The control will be administered irbesartan as a single oral dose of 150mg for the first week before escalating to 300mg for the remaining 7 weeks. Patients at \</= 50kg will receive 150mg irbesartan for the 8 week duration.
• Experimental: RE-021 (Sparsentan) - Open-Label Extension Period
  Includes all subjects who completed the Double-Blind period and enrolled in the Open-Label Extension period of the study. All subjects who completed the Double-Blind period were evaluated for response and safety at the Week 8 visit to determine eligibility for continued treatment on their assigned doses in an Open-Label Extension period for up to 496 additional weeks. Subjects treated with irbesartan during the Double-Blind period were offered sparsentan treatment at the dose they would have received according to the Double-Blind dose cohort in which they were enrolled.

Primary Outcome Measure

Percent Change in Urine Protein/Creatinine (Up/C) [ Time Frame: 8 weeks ]

Locations (28)

Find similar trials in San Diego, CA

Related Studies

• Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
  Recruiting · Kaneka Medical America LLC · Loma Linda, California
• Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
  Recruiting · Kaneka Medical America LLC · Loma Linda, California
• NEPTUNE Match Study
  Recruiting · University of Michigan · Atlanta, Georgia
• Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
  PHASE2 · Recruiting · Travere Therapeutics, Inc. · Los Angeles, California