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

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Retrophin, Inc.; Travere Therapeutics, Inc.
• Treatments: Irbesartan

Criteria

Key Inclusion Criteria for the Double-Blind Period:

• Age 18 years or older at screening

• Biopsy-proven primary IgAN

• Proteinuria of ≥1 g/day at screening

• eGFR ≥30 mL/min/1.73 m2 at screening

• Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (maximum tolerated dose and at least one-half of the maximum labeled dose)

• Systolic BP ≤150 mmHg and diastolic BP ≤100 mmHg at screening

• Willing to undergo change in ACEI and/or ARB and anti-hypertensive medications

• Agree to contraception

Key Exclusion Criteria for the Double-Blind Period:

• IgAN secondary to another condition

• Presence of cellular glomerular crescents in >25% of glomeruli on renal biopsy (if biopsy available within 6 months of screening)

• Chronic kidney disease (CKD) in addition to IgAN

• History of organ transplantation, with exception of corneal transplants

• Require any prohibited medications

• Treatment of systemic immunosuppressive medications (including corticosteroids) for >2 weeks within 3 months of screening

• History of heart failure or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and/or peripheral edema

• Clinically significant cerebrovascular disease or coronary artery disease within 6 months of screening

• Jaundice, hepatitis, or known hepatobiliary disease or elevations of transaminases (ALT/AST) >2 times upper limit of normal at screening

• History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years

• Hematocrit value <27% (0.27 V/V) or hemoglobin value <9 g/dL (90 g/L) at Screening

• Potassium >5.5 mEq/L (5.5 mmol/L) at Screening

• History of alcohol of illicit drug use disorder

• History of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan or irbesartan, or has a hypersensitivity to any of the excipients in the study medications

• For female: Pregnancy, or planning to become pregnant during the course of the study, or breastfeeding

• Participation in a study of another investigational product within 28 days of screening

Key Inclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 visit:

• Completed participation in the double-blind period, including the Week 114 visit

• Did not permanently discontinue study medication during the double-blind period

• Agree to contraception

Key Exclusion Criteria for the Open-Label Extension Period based on assessments at the Week 110 and Week 114 visits:

• Progression to end-stage renal disease (ESRD) requiring renal replacement therapy (RRT)

• Development of any criteria for discontinuation of study medication or discontinuation from the study, between Week 110 and Week 114

• Patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114

• eGFR ≤20 mL/min/1.73 m2 at Week 110

• Female patient is pregnant or breastfeeding