A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Conditions

• Immunoglobulin A Nephropathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sparsentan — DRUG
  Target dose of 400 mg daily
• irbesartan — DRUG
  Target dose of 300 mg daily
• Dapagliflozin — DRUG
  Target dose of 10 mg daily

Study Details

To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

Key Dates

Start date

Dec 11, 2018

Status verified

Mar 2026

Primary completion

Aug 7, 2023

Completion

Jul 31, 2026

Study Design

Enrollment

406 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: sparsentan
  Double-blind: Sparsentan will be administered daily as a 200-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 200 mg after 2 weeks will increase their dose to 400- mg and continue treatment to Week 110.
• Active Comparator: irbesartan
  Double-blind: Irbesartan will be administered daily as a 150-mg oral tablet, over-encapsulated (blinded) size 00 capsule for the first 2 weeks of the study following randomization. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg and continue treatment to Week 110.
• Experimental: dapagliflozin + sparsentan (Sub study)
  OLE Sub study: Dapagliflozin will be administered daily as a 5-mg oral tablet, in addition to 400-mg of Sparsentan, for a period of 12 weeks.
• Experimental: sparsentan (Sub Study)
  OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36 [ Time Frame: Baseline (Day 1) and at Week 36 ]

Locations (40)

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