A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
NCT ID: NCT03762850
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
406 participants
INTERVENTIONAL
2018-12-11
2026-07-31
Brief Summary
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Detailed Description
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The purpose of the study is to evaluate the potential benefit of sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.
Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be those at high risk of progressing to renal failure. They will be randomly assigned in a 1:1 ratio to either sparsentan or irbesartan, as the active control (current standard treatment) at the Day 1 (Randomization) visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose.
The primary analysis is change in proteinuria (urine protein/creatinine ratio) from baseline at Week 36 in sparsentan-treated patients as compared to irbesartan-treated patients.
Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study.
Patients participating in the open-label extension period may be evaluated for eligibility to participate in a randomized, open-label, controlled Sub study evaluating the safety and efficacy of an SGLT2 inhibitor in addition to stable sparsentan treatment (OLE Sub study). The SGLT2 inhibitor, dapagliflozin will be provided as "study medication" for the OLE Sub study. Following completion of the visit 12 weeks after the OLE baseline visit, eligible patients may receive open-label dapagliflozin for at least 12 weeks but up to 24 additional weeks, or through the end of the open-label extension period, whichever is shortest. Approximately 60 patients from the open-label extension period will be enrolled into the OLE Sub study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
sparsentan
Target dose of 400 mg daily
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.
irbesartan
Target dose of 300 mg daily
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.
sparsentan
Target dose of 400 mg daily
Dapagliflozin
Target dose of 10 mg daily
sparsentan (Sub Study)
OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.
sparsentan
Target dose of 400 mg daily
Interventions
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sparsentan
Target dose of 400 mg daily
irbesartan
Target dose of 300 mg daily
Dapagliflozin
Target dose of 10 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
Exclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Travere Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Radko Komers, MD, PhD
Role: STUDY_DIRECTOR
Travere Therapeutics, Inc.
Locations
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Travere Investigational Site
Birmingham, Alabama, United States
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Homewood, Alabama, United States
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Glendale, California, United States
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Montebello, California, United States
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Northridge, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Stanford, California, United States
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Denver, Colorado, United States
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Coral Springs, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Winter Park, Florida, United States
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Lawrenceville, Georgia, United States
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Nampa, Idaho, United States
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Hinsdale, Illinois, United States
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Muncie, Indiana, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Reno, Nevada, United States
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Fresh Meadows, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lewisville, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Tacoma, Washington, United States
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Marshfield, Wisconsin, United States
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Concord, New South Wales, Australia
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Gosford, New South Wales, Australia
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Kingswood, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Randwick, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Birtinya, Queensland, Australia
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Adelaide, South Australia, Australia
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Reservoir, Victoria, Australia
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Nedlands, Western Australia, Australia
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Bonheiden, , Belgium
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Bruges, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Osijek, , Croatia
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Zagreb, , Croatia
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Prague, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Marseille, Bouches-du-Rhone, France
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Montpellier, Herault, France
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Grenoble, Isere, France
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Paris, Paris, France
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Saint-Priest-en-Jarez, Pays de la Loire Region, France
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Clermont-Ferrand, Puy De Dome, France
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Créteil, , France
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Paris, , France
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
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Hanover, Lower Saxony, Germany
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Aachen, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Kaiserslautern, Rheinland Palatinate, Germany
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Trier, Rheinland Palatinate, Germany
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Kiel, Schleswig-Holstein, Germany
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Kiel, Schleswig-Holstein, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Kwun Tong, Kowloon, Hong Kong
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Lai Chi Kok, Kowloon, Hong Kong
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Shatin, New Territories, Hong Kong
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Tsuen Wan, New Territories, Hong Kong
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Hong Kong, , Hong Kong
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Ranica, Bergamo, Italy
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Milan, Lombardy, Italy
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Bari, , Italy
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Catania, , Italy
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Catanzaro, , Italy
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Lecco, , Italy
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Modena, , Italy
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Pavia, , Italy
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Roma, , Italy
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Torino, , Italy
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Grafton, Auckland, New Zealand
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Hamilton, , New Zealand
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Hastings, , New Zealand
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New Plymouth, , New Zealand
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Loures, , Portugal
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Setúbal, , Portugal
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Vila Nova de Gaia, , Portugal
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Seongnam-si, Gyeonggi-do, South Korea
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Anyang-si, , South Korea
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Busan, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Palma de Mallorca, Balearic Islands, Spain
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Sagunto, Valencia, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Reading, Berkshire, United Kingdom
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Cambridge, Cambridgeshire, United Kingdom
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Middlesbrough, Cleveland, United Kingdom
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Derby, Derbyshire, United Kingdom
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Brighton, East Sussex, United Kingdom
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London, Greater London, United Kingdom
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London, Greater London, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Salford, Greater Manchester, United Kingdom
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Preston, Lancashire, United Kingdom
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Leicester, Leicestershire, United Kingdom
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Edinburgh, Scotland, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Glasgow, Strathclyde, United Kingdom
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Carshalton, Surrey, United Kingdom
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Cardiff, West Glamorgan, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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References
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Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
Rovin BH, Barratt J, Heerspink HJL, Alpers CE, Bieler S, Chae DW, Diva UA, Floege J, Gesualdo L, Inrig JK, Kohan DE, Komers R, Kooienga LA, Lafayette R, Maes B, Malecki R, Mercer A, Noronha IL, Oh SW, Peh CA, Praga M, Preciado P, Radhakrishnan J, Rheault MN, Rote WE, Tang SCW, Tesar V, Trachtman H, Trimarchi H, Tumlin JA, Wong MG, Perkovic V; DUPRO steering committee and PROTECT Investigators. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023 Dec 2;402(10417):2077-2090. doi: 10.1016/S0140-6736(23)02302-4. Epub 2023 Nov 3.
Obadina M, Wilson S, Derebail VK, Little J. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations. Kidney360. 2023 Jul 1;4(7):997-1005. doi: 10.34067/KID.0000000000000162. Epub 2023 May 31.
Heerspink HJL, Radhakrishnan J, Alpers CE, Barratt J, Bieler S, Diva U, Inrig J, Komers R, Mercer A, Noronha IL, Rheault MN, Rote W, Rovin B, Trachtman H, Trimarchi H, Wong MG, Perkovic V; PROTECT Investigators. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023 May 13;401(10388):1584-1594. doi: 10.1016/S0140-6736(23)00569-X. Epub 2023 Apr 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Sponsor Website
Other Identifiers
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2017-004605-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
021IGAN17001
Identifier Type: -
Identifier Source: org_study_id
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