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NCT03762850

PHASE3

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

Sponsor: Travere Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Official title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2018-12-11

Completion Date

2026-08-19

Last Updated

2026-10-14

Healthy Volunteers

Conditions

Immunoglobulin A Nephropathy

Interventions

DRUG

sparsentan

Target dose of 400 mg daily

DRUG

irbesartan

Target dose of 300 mg daily

DRUG

Dapagliflozin

Target dose of 10 mg daily

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

Locations (162)

Travere Investigational Site

Birmingham, Alabama, United States

Travere Investigational Site

Homewood, Alabama, United States

Travere Investigational Site

Glendale, California, United States

Travere Investigational Site

Montebello, California, United States

Travere Investigational Site

Northridge, California, United States

Travere Investigational Site

San Diego, California, United States

Travere Investigational Site

San Diego, California, United States

Travere Investigational Site

Stanford, California, United States

Travere Investigational Site

Denver, Colorado, United States

Travere Investigational Site

Coral Springs, Florida, United States

Travere Investigational Site

Hollywood, Florida, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Miami, Florida, United States

Travere Investigational Site

Winter Park, Florida, United States

Travere Investigational Site

Lawrenceville, Georgia, United States

Travere Investigational Site

Nampa, Idaho, United States

Travere Investigational Site

Hinsdale, Illinois, United States

Travere Investigational Site

Muncie, Indiana, United States

Travere Investigational Site

Kansas City, Kansas, United States

Travere Investigational Site

Louisville, Kentucky, United States

Travere Investigational Site

Boston, Massachusetts, United States

Travere Investigational Site

Springfield, Massachusetts, United States

Travere Investigational Site

Worcester, Massachusetts, United States

Travere Investigational Site

Minneapolis, Minnesota, United States

Travere Investigational Site

Reno, Nevada, United States

Travere Investigational Site

Fresh Meadows, New York, United States

Travere Investigational Site

New York, New York, United States

Travere Investigational Site

Cleveland, Ohio, United States

Travere Investigational Site

Columbus, Ohio, United States

Travere Investigational Site

Philadelphia, Pennsylvania, United States

Travere Investigational Site

Columbia, South Carolina, United States

Travere Investigational Site

El Paso, Texas, United States

Travere Investigational Site

Fort Worth, Texas, United States

Travere Investigational Site

Houston, Texas, United States

Travere Investigational Site

Lewisville, Texas, United States

Travere Investigational Site

San Antonio, Texas, United States

Travere Investigational Site

Salt Lake City, Utah, United States

Travere Investigational Site

Salt Lake City, Utah, United States

Travere Investigational Site

Tacoma, Washington, United States

Travere Investigational Site

Marshfield, Wisconsin, United States

Travere Investigational Site

Concord, New South Wales, Australia

Travere Investigational Site

Gosford, New South Wales, Australia

Travere Investigational Site

Kingswood, New South Wales, Australia

Travere Investigational Site

New Lambton Heights, New South Wales, Australia

Travere Investigational Site

Randwick, New South Wales, Australia

Travere Investigational Site

St Leonards, New South Wales, Australia

Travere Investigational Site

Birtinya, Queensland, Australia

Travere Investigational Site

Adelaide, South Australia, Australia

Travere Investigational Site

Reservoir, Victoria, Australia

Travere Investigational Site

Nedlands, Western Australia, Australia

Travere Investigational Site

Bonheiden, Belgium

Travere Investigational Site

Bruges, Belgium

Travere Investigational Site

Ghent, Belgium

Travere Investigational Site

Kortrijk, Belgium

Travere Investigational Site

Liège, Belgium

Travere Investigational Site

Roeselare, Belgium

Travere Investigational Site

Osijek, Croatia

Travere Investigational Site

Zagreb, Croatia

Travere Investigational Site

Prague, Czechia

Travere Investigational Site

Prague, Czechia

Travere Investigational Site

Tallinn, Estonia

Travere Investigational Site

Tallinn, Estonia

Travere Investigational Site

Tartu, Estonia

Travere Investigational Site

Marseille, Bouches-du-Rhone, France

Travere Investigational Site

Montpellier, Herault, France

Travere Investigational Site

Grenoble, Isere, France

Travere Investigational Site

Paris, Paris, France

Travere Investigational Site

Saint-Priest-en-Jarez, Pays de la Loire Region, France

Travere Investigational Site

Clermont-Ferrand, Puy De Dome, France

Travere Investigational Site

Créteil, France

Travere Investigational Site

Paris, France

Travere Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Travere Investigational Site

Hanover, Lower Saxony, Germany

Travere Investigational Site

Aachen, North Rhine-Westphalia, Germany

Travere Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

Travere Investigational Site

Kaiserslautern, Rheinland Palatinate, Germany

Travere Investigational Site

Trier, Rheinland Palatinate, Germany

Travere Investigational Site

Kiel, Schleswig-Holstein, Germany

Travere Investigational Site

Kiel, Schleswig-Holstein, Germany

Travere Investigational Site

Jena, Thuringia, Germany

Travere Investigational Site

Berlin, Germany

Travere Investigational Site

Kwun Tong, Kowloon, Hong Kong

Travere Investigational Site

Lai Chi Kok, Kowloon, Hong Kong

Travere Investigational Site

Shatin, New Territories, Hong Kong

Travere Investigational Site

Tsuen Wan, New Territories, Hong Kong

Travere Investigational Site

Hong Kong, Hong Kong

Travere Investigational Site

Ranica, Bergamo, Italy

Travere Investigational Site

Milan, Lombardy, Italy

Travere Investigational Site

Bari, Italy

Travere Investigational Site

Catania, Italy

Travere Investigational Site

Catanzaro, Italy

Travere Investigational Site

Lecco, Italy

Travere Investigational Site

Modena, Italy

Travere Investigational Site

Pavia, Italy

Travere Investigational Site

Roma, Italy

Travere Investigational Site

Torino, Italy

Travere Investigational Site

Kaunas, Lithuania

Travere Investigational Site

Vilnius, Lithuania

Travere Investigational Site

Grafton, Auckland, New Zealand

Travere Investigational Site

Hamilton, New Zealand

And 62 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (162)