Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Chronic Kidney Disease
Enrollment Eligibility
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
Key Inclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:
- Participating in the open-label extension and is willing and able to provide signed
informed consent for participation in the open-label extension period Sub study
- A urine protein excretion value of ≥0.3 g/day.
- An eGFR of ≥25 mL/min/1.73m2
- On a stable dose of sparsentan for ≥8 weeks in the open-label extension period that is
the maximum tolerated dose.
Key Exclusion Criteria for the OLE Sparsentan + SGLT2 Inhibitor Sub study:
- Progressed to ESRD requiring RRT
- Initiated or changed dose of a systemic immunosuppressive medication (including
systemic steroids) within 12 weeks
- Taking an SGLT2 inhibitor within 12 weeks