Clinical trial NCT05856760: A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
Official title: A Multicentered, Single-group Phase 2, Exploratory, Open-label Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in the Treatment of Adult Participants With IgAN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immunoglobulin A Nephropathy
Keywords: IgAN
Lead sponsor: Travere Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

Detailed description: This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry.

Participants who provide written informed consent will be assessed for eligibility and will undergo baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants are required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and will continue their stable treatments through the screening period. Eligible participants will discontinue ACEI and/or ARB therapy the day before the Day 1 visit and remain on stable SGLT2 inhibitor dosing for the duration of the study.

Study intervention will be administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention will be discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years at the time of signing the informed consent.
* Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.
* UA/C ≥0.3 g/g at screening
* An eGFR value of ≥25 mL/min/1.73m2 at screening.
* On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.
* On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:

  * The participant's maximum tolerated dose (MTD), and
  * at least one half of the maximum labeled dose (MLD)

Exclusion Criteria:

* IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.
* Undergone any organ transplant, with the exception of corneal transplants.
* Documented history of heart failure, clinically significant cardiovascular or liver disease.
* Taking high dose (defined as \>10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.

Primary outcomes:
measure: Change in urine albumin-creatinine ratio (UA/C) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: UA/C <0.2 g/g at Week 24
timeFrame: Week 24
measure: 30% and 50% reduction from baseline in UA/C at Week 24
timeFrame: Week 24
measure: UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit
timeFrame: Week 24
measure: Estimated glomerular filtration rate (eGFR) at each visit
timeFrame: Week 24
measure: Blood pressure (BP) at each visit
timeFrame: Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Travere Investigational Site
state: Alabama
city: Chula Vista
country: United States
facility: Travere Investigational Site
state: California
city: Garden Grove
country: United States
facility: Travere Investigational Site
state: California
city: Glendale
country: United States
facility: Travere Investigational Site
state: California
city: Denver
country: United States
facility: Travere Investigational Site
state: Colorado
city: Boise
country: United States
facility: Travere Investigational Site
state: Idaho
city: Chubbuck
country: United States
facility: Travere Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: Travere Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Travere Investigational Site
state: Illinois
city: Evergreen Park
country: United States
facility: Travere Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Travere Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Travere Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Travere Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Travere Investigational Site
state: Louisiana
city: Albuquerque
country: United States
facility: Travere Investigational Site
state: New Mexico
city: Clifton Park
country: United States
facility: Travere Investigation SIte
state: New York
city: Fresh Meadows
country: United States
facility: Travere Investigational Site
state: New York
city: New York
country: United States
facility: Travere Investigational Site
state: New York
city: Jacksonville
country: United States
facility: Travere Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Travere Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Travere Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Travere Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Travere Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Travere Investigational Site
state: Texas
city: Dallas
country: United States
facility: Travere Investigational Site
state: Texas
city: Hong Kong
country: Hong Kong
facility: Travere Investigational Site
city: Kowloon
country: Hong Kong
facility: Travere Investigational Site
city: Shatin
country: Hong Kong
facility: Travere Investigational Site
city: Sheung Wan
country: Hong Kong
facility: Travere Investigational Site
city: Tsuen Wan
country: Hong Kong
facility: Travere Investigational Site
Study officials:
affiliation: Travere Therapeutics, Inc.
name: Radko Komers, MD, PhD
role: STUDY_DIRECTOR
References: