Trial Outcomes & Findings for A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN (NCT NCT05856760)

NCT ID: NCT05856760

Last Updated: 2025-11-20

Results Overview

The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2025-11-20

Participant Flow

Forty-eight participants were enrolled in the study and all 48 (100%) received at least 1 dose of sparsentan. Sparsentan was prematurely discontinued in 9 participants (19%). Forty-one participants (85%) completed the study, and 7 participants (15%) discontinued the study. The most common reasons for discontinuation from the study were withdrawal by participant (3 participants [6%]) and AEs (2 participants [4%]).

93 participants were screened; 45 participants were screen failures. * 29 participants did not meet the inclusion criteria of UA/C ≥0.3 g/g * 7 participants did not meet the inclusion criteria of being on a stable dose of ACEI and/or ARB * 5 participants did not meet the inclusion criteria of being on a stable dose of an SGLT2 inhibitor * 4 participants were excluded for other reasons

Participant milestones

Measure	Sparsentan 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. Sparsentan: Target dose of 400 mg daily
Overall Study STARTED	48
Overall Study Discontinued	7
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Sparsentan 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. Sparsentan: Target dose of 400 mg daily
Overall Study Adverse Event	2
Overall Study Physician Decision	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sparsentan n=48 Participants 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. Sparsentan: Target dose of 400 mg daily
Age, Continuous	48 years
Sex: Female, Male Female	20 Participants
Sex: Female, Male Male	28 Participants
Race/Ethnicity, Customized Race · White	28 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants
Race/Ethnicity, Customized Race · Asian	19 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	42 Participants
Race/Ethnicity, Customized Ethnicity · Not Reported	1 Participants
Region of Enrollment Hong Kong	11 participants
Region of Enrollment United States	37 participants
Height	168.2 centimeters STANDARD_DEVIATION 11.16
Weight	85.9 Kilograms STANDARD_DEVIATION 22.25
BMI	30.02 kg/m^2 STANDARD_DEVIATION 5.619
Estimated Glomerular Filtration Rate (eGFR) <25 mL/min/1.73m^2	0 participants
Estimated Glomerular Filtration Rate (eGFR) >/=25 to <60 mL/min/173m^2	33 participants
Estimated Glomerular Filtration Rate (eGFR) >/=60 mL/min/1.73m^2	15 participants
Urine protein/creatinine ratio (UP/C)	1.29 g/g
Urine albumin/creatinine ratio (UA/C)	0.75 g/g

PRIMARY outcome

Timeframe: Week 24

Population: Full Analysis Set

The change from baseline in UA/C at Week 24 based on first morning void (FMV) samples

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24	-55.78 percent change Interval -65.8 to -42.8

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

Achievement of UA/C of <0.2 g/g at Week 24 based on FMV samples

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
UA/C <0.2 g/g at Week 24	31 percentage of participants Interval 17.0 to 47.6

SECONDARY outcome

Timeframe: Week 24

Population: UA/C Responder Endpoints While on Treatment

Achievement of 30% reduction from baseline in UA/C at Week 24 based on FMV samples

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
30% Reduction From Baseline in UA/C at Week 24	77 percentage of participants Interval 60.7 to 88.9

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

Achievement of 50% reduction from baseline in UA/C at Week 24 based on FMV samples

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
50% Reduction From Baseline in UA/C at Week 24	51 percentage of participants Interval 34.8 to 67.6

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

The change from baseline in UP/C at Week 24 based on FMV samples

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
Change in Urine Protein-to-creatinine Ratio (UP/C) at Week 24	-45.20 percentage change Interval -54.6 to -33.9

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

Change from baseline estimated glomerular filtration rate at 24 weeks

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
Estimated Glomerular Filtration Rate (eGFR)	-2.0 mL/min/1.73 square meter Interval -3.9 to -0.1

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

The change from baseline in systolic BP at Week 24

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
Systolic Blood Pressure (BP) at Week 24	-3.4 mmHg Interval -6.8 to 0.0

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

The change from baseline in diastolic BP at Week 24

Outcome measures

Measure	Sparsentan n=39 Participants 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. Sparsentan: Target dose of 400 mg daily
Change in Diastolic Blood Pressure (BP)	-4.6 mmHg Interval -6.7 to -2.4

Adverse Events

Sparsentan

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sparsentan n=48 participants at risk 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. Sparsentan: Target dose of 400 mg daily
Musculoskeletal and connective tissue disorders Osteoarthritis	2.1% 1/48 • Number of events 1 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Nervous system disorders Cerebrovascular event	2.1% 1/48 • Number of events 1 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Renal and urinary disorders Acute kidney injury	2.1% 1/48 • Number of events 1 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Vascular disorders Deep vein thrombosis	2.1% 1/48 • Number of events 1 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Injury, poisoning and procedural complications Chemical burn	2.1% 1/48 • Number of events 1 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)

Other adverse events

Measure	Sparsentan n=48 participants at risk 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. Sparsentan: Target dose of 400 mg daily
Vascular disorders Hypotension	14.6% 7/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Nervous system disorders Headache	8.3% 4/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
General disorders Oedema	8.3% 4/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
General disorders Oedema peripheral	8.3% 4/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Infections and infestations Upper respiratory tract infection	8.3% 4/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)
Nervous system disorders Dizziness	6.2% 3/48 • 525 Days (1 year, 5 months, and 6 days) Continuous monitoring from Day -42 (screening) to Week 28 (safety follow-up visit)

Additional Information

Travere Therapeutics Call Center

Travere Therapeutics, Inc.

Phone: 1-877-659-5518

Email: medinfo@travere.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER