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A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN (SPARTACUS)

Primary Purpose

Immunoglobulin A Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sparsentan
Sponsored by
Travere Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunoglobulin A Nephropathy focused on measuring IgAN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Travere Investigational SiteRecruiting
  • Travere Investigational Site
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting
  • Travere Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sparsentan

Arm Description

Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.

Outcomes

Primary Outcome Measures

Change in urine albumin-creatinine ratio (UA/C) at Week 24
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples

Secondary Outcome Measures

UA/C <0.2 g/g at Week 24
Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples
30% and 50% reduction from baseline in UA/C at Week 24
Achievement of 30% and 50% reduction from baseline in UA/C at Week 24 based on FMV samples
UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit
Change from baseline in UA/C and UP/C at each visit based on FMV samples
Estimated glomerular filtration rate (eGFR) at each visit
Change from baseline eGFR at each visit
Blood pressure (BP) at each visit
Change from baseline systolic and diastolic BP at each visit.

Full Information

First Posted
May 3, 2023
Last Updated
September 14, 2023
Sponsor
Travere Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05856760
Brief Title
A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
Acronym
SPARTACUS
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Travere Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunoglobulin A Nephropathy
Keywords
IgAN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sparsentan
Arm Type
Experimental
Arm Description
Sparsentan will be administered daily as a 200-mg oral tablet. The goal is to titrate from the initial dose of 200 mg (Day 1) to the target dose of 400 mg at Week 2.
Intervention Type
Drug
Intervention Name(s)
Sparsentan
Other Intervention Name(s)
Filspari, RE-021
Intervention Description
Target dose of 400 mg daily
Primary Outcome Measure Information:
Title
Change in urine albumin-creatinine ratio (UA/C) at Week 24
Description
The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
UA/C <0.2 g/g at Week 24
Description
Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples
Time Frame
Week 24
Title
30% and 50% reduction from baseline in UA/C at Week 24
Description
Achievement of 30% and 50% reduction from baseline in UA/C at Week 24 based on FMV samples
Time Frame
Week 24
Title
UA/C and Urine protein-to-creatinine ratio (UP/C) at each visit
Description
Change from baseline in UA/C and UP/C at each visit based on FMV samples
Time Frame
Week 24
Title
Estimated glomerular filtration rate (eGFR) at each visit
Description
Change from baseline eGFR at each visit
Time Frame
Week 24
Title
Blood pressure (BP) at each visit
Description
Change from baseline systolic and diastolic BP at each visit.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Travere Call Center
Phone
1-877-659-5518
Email
medinfo@travere.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila Preciado, MD
Organizational Affiliation
Travere Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Travere Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Individual Site Status
Completed
Facility Name
Travere Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Individual Site Status
Recruiting
Facility Name
Travere Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://travere.com
Description
Sponsor Website

Learn more about this trial

A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

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