- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762850
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a 114-week,randomized, multicenter, double-blind, parallel-group, active-control study with an open-label extension period of up to 156 weeks, for a total duration of up to 270 weeks in patients with IgAN who have persistent overt proteinuria and remain at high risk of disease progression despite being on a stable dose (or doses) of an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) that is (are) a maximum tolerated dose that is at least one half of the maximum labeled dose (MLD) (according to approved labeling. Approximately 380 patients aged ≥18 years will be enrolled in the study globally. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan.
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Concord, New South Wales, Australia, 2139
- Travere Investigational Site
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Gosford, New South Wales, Australia, 2250
- Travere Investigational Site
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Kingswood, New South Wales, Australia, 2747
- Travere Investigational Site
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New Lambton Heights, New South Wales, Australia, 2305
- Travere Investigational Site
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Randwick, New South Wales, Australia, 2031
- Travere Investigational Site
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St Leonards, New South Wales, Australia, 2065
- Travere Investigational Site
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Queensland
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Birtinya, Queensland, Australia, 4575
- Travere Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Travere Investigational Site
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Victoria
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Reservoir, Victoria, Australia, 3073
- Travere Investigational Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Travere Investigational Site
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Bonheiden, Belgium, 2820
- Travere Investigational Site
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Brugge, Belgium, 8310
- Travere Investigational Site
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Gent, Belgium, 9000
- Travere Investigational Site
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Kortrijk, Belgium, 8500
- Travere Investigational Site
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Liège, Belgium, 4000
- Travere Investigational Site
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Roeselare, Belgium, 8800
- Travere Investigational Site
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Osijek, Croatia, 31000
- Travere Investigational Site
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Zagreb, Croatia, 10000
- Travere Investigational Site
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Praha 10, Czechia, 10034
- Travere Investigational Site
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Praha 2, Czechia, 12808
- Travere Investigational Site
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Tallinn, Estonia, 10617
- Travere Investigational Site
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Tallinn, Estonia, 13419
- Travere Investigational Site
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Tartu, Estonia, 50406
- Travere Investigational Site
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Créteil, France, 94010
- Travere Investigational Site
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Paris, France, 75475
- Travere Investigational Site
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, France, 13005
- Travere Investigational Site
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Herault
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Montpellier Cedex 5, Herault, France, 34295
- Travere Investigational Site
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Isere
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Grenoble Cedex 9, Isere, France, 38043
- Travere Investigational Site
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Loire
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Saint-Priest-en-Jarez, Loire, France, 42270
- Travere Investigational Site
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Paris
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Paris Cedex 15, Paris, France, 75015
- Travere Investigational Site
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Puy De Dome
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Clermont Ferrand Cedex, Puy De Dome, France, 63003
- Travere Investigational Site
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Berlin, Germany, 10117
- Travere Investigational Site
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Baden Wuerttemberg
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Villingen-Schwenningen, Baden Wuerttemberg, Germany, 78052
- Travere Investigational Site
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30625
- Travere Investigational Site
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Nordrhein Westfalen
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Duesseldorf, Nordrhein Westfalen, Germany, 40210
- Travere Investigational Site
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North Rhine Westphalia
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Aachen, North Rhine Westphalia, Germany, 52074
- Travere Investigational Site
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Rheinland Palatinate
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Kaiserslautern, Rheinland Palatinate, Germany, 67655
- Travere Investigational Site
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Trier, Rheinland Palatinate, Germany, 54292
- Travere Investigational Site
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Schleswig Holstein
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Kiel, Schleswig Holstein, Germany, 23538
- Travere Investigational Site
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- Travere Investigational Site
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Thueringen
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Jena, Thueringen, Germany, 07747
- Travere Investigational Site
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Hong Kong, Hong Kong
- Travere Investigational Site
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Kowloon
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Kwun Tong, Kowloon, Hong Kong
- Travere Investigational Site
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Lai Chi Kok, Kowloon, Hong Kong
- Travere Investigational Site
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New Territories
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Shatin, New Territories, Hong Kong
- Travere Investigational Site
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Tsuen Wan, New Territories, Hong Kong
- Travere Investigational Site
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Bari, Italy, 70124
- Travere Investigational Site
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Catania, Italy, 95123
- Travere Investigational Site
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Catanzaro, Italy, 88100
- Travere Investigational Site
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Lecco, Italy, 23900
- Travere Investigational Site
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Modena, Italy, 41124
- Travere Investigational Site
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Pavia, Italy, 27100
- Travere Investigational Site
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Roma, Italy, 00168
- Travere Investigational Site
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Torino, Italy, 10126
- Travere Investigational Site
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Bergamo
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Ranica, Bergamo, Italy, 24020
- Travere Investigational Site
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Lombardia
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Milan, Lombardia, Italy, 20162
- Travere Investigational Site
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Anyang-Si, Korea, Republic of, 14068
- Travere Investigational Site
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Busan, Korea, Republic of, 47392
- Travere Investigational Site
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Incheon, Korea, Republic of, 21565
- Travere Investigational Site
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Seoul, Korea, Republic of, 02841
- Travere Investigational Site
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Seoul, Korea, Republic of, 03080
- Travere Investigational Site
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Seoul, Korea, Republic of, 06273
- Travere Investigational Site
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Seoul, Korea, Republic of, 110-746
- Travere Investigational Site
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Seoul, Korea, Republic of, 120-752
- Travere Investigational Site
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Seoul, Korea, Republic of, 135-710
- Travere Investigational Site
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Travere Investigational Site
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Kaunas, Lithuania, LT-50009
- Travere Investigational Site
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Vilnius, Lithuania, LT-08661
- Travere Investigational Site
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Hamilton, New Zealand, 3200
- Travere Investigational Site
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Hastings, New Zealand, 4120
- Travere Investigational Site
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New Plymouth, New Zealand, 4342
- Travere Investigational Site
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Auckland
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Grafton, Auckland, New Zealand, 1142
- Travere Investigational Site
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Kraków, Poland, 31-559
- Travere Investigational Site
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Olsztyn, Poland, 10-124
- Travere Investigational Site
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Olsztyn, Poland, 10-561
- Travere Investigational Site
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Warszawa, Poland, 04-749
- Travere Investigational Site
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Wrocław, Poland, 50-566
- Travere Investigational Site
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Łódź, Poland, 93-347
- Travere Investigational Site
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Coimbra, Portugal, 3000-075
- Travere Investigational Site
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Lisboa, Portugal, 1069-166
- Travere Investigational Site
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Lisboa, Portugal, 1649-035
- Travere Investigational Site
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Loures, Portugal, 2674-514
- Travere Investigational Site
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Setúbal, Portugal, 2910-446
- Travere Investigational Site
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Vila Nova De Gaia, Portugal, 4434-502
- Travere Investigational Site
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Barcelona, Spain, 08003
- Travere Investigational Site
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Barcelona, Spain, 08025
- Travere Investigational Site
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Barcelona, Spain, 08035
- Travere Investigational Site
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Barcelona, Spain, 08036
- Travere Investigational Site
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Madrid, Spain, 28007
- Travere Investigational Site
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Madrid, Spain, 28040
- Travere Investigational Site
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Madrid, Spain, 28041
- Travere Investigational Site
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Sevilla, Spain, 41009
- Travere Investigational Site
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Valencia, Spain, 46014
- Travere Investigational Site
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Valencia, Spain, 46017
- Travere Investigational Site
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Zaragoza, Spain, 50009
- Travere Investigational Site
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Baleares
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Palma De Mallorca, Baleares, Spain, 07120
- Travere Investigational Site
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Valencia
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Sagunto, Valencia, Spain, 46520
- Travere Investigational Site
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Hualien City, Taiwan, 970
- Travere Investigational Site
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Kaohsiung, Taiwan, 807
- Travere Investigational Site
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Kaohsiung, Taiwan, 81362
- Travere Investigational Site
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New Taipei City, Taiwan, 220
- Travere Investigational Site
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Taichung, Taiwan, 40705
- Travere Investigational Site
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Liverpool, United Kingdom, L9 7AL
- Travere Investigational Site
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London, United Kingdom, SE5 9RS
- Travere Investigational Site
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London, United Kingdom, E1 1FR
- Travere Investigational Site
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Berkshire
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Reading, Berkshire, United Kingdom, RG1 5AN
- Travere Investigational Site
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
- Travere Investigational Site
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Cleveland
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Middlesbrough, Cleveland, United Kingdom, TS4 3BW
- Travere Investigational Site
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Derbyshire
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Derby, Derbyshire, United Kingdom, DE22 3DT
- Travere Investigational Site
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East Sussex
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Brighton, East Sussex, United Kingdom, BN2 5BE
- Travere Investigational Site
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Greater London
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London, Greater London, United Kingdom, E1 4AT
- Travere Investigational Site
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London, Greater London, United Kingdom, SE1 9RT
- Travere Investigational Site
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M13 9WL
- Travere Investigational Site
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Salford, Greater Manchester, United Kingdom, M6 8HD
- Travere Investigational Site
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Lancashire
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Preston, Lancashire, United Kingdom, PR2 9HT
- Travere Investigational Site
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Leicestershire
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Leicester, Leicestershire, United Kingdom, LE5 4PW
- Travere Investigational Site
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Scotland
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Edinburgh, Scotland, United Kingdom, EH16 4SA
- Travere Investigational Site
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Staffordshire
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
- Travere Investigational Site
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Strathclyde
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Glasgow, Strathclyde, United Kingdom, G11 6NT
- Travere Investigational Site
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Surrey
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Carshalton, Surrey, United Kingdom, SM5 1AA
- Travere Investigational Site
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West Glamorgan
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Cardiff, West Glamorgan, United Kingdom, CF14 4XW
- Travere Investigational Site
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West Midlands
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Birmingham, West Midlands, United Kingdom, B9 5SS
- Travere Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35233
- Travere Investigational Site
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Homewood, Alabama, United States, 35209
- Travere Investigational Site
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California
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Glendale, California, United States, 91206
- Travere Investigational Site
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Montebello, California, United States, 90640
- Travere Investigational Site
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Northridge, California, United States, 91324
- Travere Investigational Site
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San Diego, California, United States, 92103-6204
- Travere Investigational Site
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San Diego, California, United States, 92103
- Travere Investigational Site
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Stanford, California, United States, 94205
- Travere Investigational Site
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Colorado
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Denver, Colorado, United States, 80230
- Travere Investigational Site
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Florida
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Coral Springs, Florida, United States, 33071
- Travere Investigational Site
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Hollywood, Florida, United States, 33021
- Travere Investigational Site
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Miami, Florida, United States, 33136
- Travere Investigational Site
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Miami, Florida, United States, 33186
- Travere Investigational Site
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Winter Park, Florida, United States, 32789
- Travere Investigational Site
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Georgia
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Lawrenceville, Georgia, United States, 30046
- Travere Investigational Site
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Idaho
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Nampa, Idaho, United States, 83687
- Travere Investigational Site
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Illinois
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Hinsdale, Illinois, United States, 60521
- Travere Investigational Site
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Indiana
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Muncie, Indiana, United States, 47303
- Travere Investigational Site
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Kansas
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Kansas City, Kansas, United States, 66160
- Travere Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40202
- Travere Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Travere Investigational Site
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Springfield, Massachusetts, United States, 01104
- Travere Investigational Site
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Worcester, Massachusetts, United States, 01608
- Travere Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Travere Investigational Site
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Nevada
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Reno, Nevada, United States, 89511
- Travere Investigational Site
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New York
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Fresh Meadows, New York, United States, 11365
- Travere Investigational Site
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New York, New York, United States, 10032
- Travere Investigational Site
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Ohio
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Cleveland, Ohio, United States, 44106
- Travere Investigational Site
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Columbus, Ohio, United States, 43210
- Travere Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Travere Investigational Site
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South Carolina
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Columbia, South Carolina, United States, 29203
- Travere Investigational Site
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Texas
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El Paso, Texas, United States, 79935
- Travere Investigational Site
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Fort Worth, Texas, United States, 76104
- Travere Investigational Site
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Houston, Texas, United States, 77054
- Travere Investigational Site
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Lewisville, Texas, United States, 75057
- Travere Investigational Site
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San Antonio, Texas, United States, 78207
- Travere Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84115
- Travere Investigational Site
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Salt Lake City, Utah, United States, 84132
- Travere Investigational Site
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Washington
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Tacoma, Washington, United States, 98405
- Travere Investigational Site
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Travere Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Target dose of 400 mg daily
Other Names:
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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.
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Target dose of 300 mg daily
Other Names:
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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.
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Target dose of 400 mg daily
Other Names:
Target dose of 10 mg daily
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Experimental: sparsentan (Sub Study)
OLE Sub study: Sparsentan will be administered daily as a dose of 400-mg for a period of 12 weeks.
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Target dose of 400 mg daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Urine protein/creatinine ratio (UP/C) at Week 36
Time Frame: After the last patient randomized has undergone the Week 36 visit
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The primary efficacy endpoint is the change from baseline (Day 1) in the UP/C based on a 24-hour urine sample at Week 36.
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After the last patient randomized has undergone the Week 36 visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
eGFR over a 52-week period
Time Frame: Week 58 postrandomization
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The rate of change in estimated glomerular filtration rate (eGFR) over a 52-week period following the initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 58 weeks postrandomization eGFR chronic slope at 1 year.)
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Week 58 postrandomization
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eGFR over a 104-week period
Time Frame: Week 110 postrandomization
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The rate of change in estimated glomerular filtration rate (eGFR) over a 104-week period following initial acute effect of randomized therapy (the initial acute effect of randomized therapy is defined as the first 6 weeks of randomized treatment with study medication; thus, the analysis is from 6 weeks postrandomization to 110 weeks postrandomization eGFR chronic slope at 2 years.)
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Week 110 postrandomization
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eGFR over a 110-week period
Time Frame: Week 110 postrandomization
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The rate of change in eGFR over a 110-week (approximately 2 years) period following the initiation of randomized therapy (thus, the analysis is from Day 1 to 110 weeks postrandomization eGFR total slope at 2 years).
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Week 110 postrandomization
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Priscila Preciado, MD, Travere Therapeutics, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Glomerulonephritis, IGA
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Sodium-Glucose Transporter 2 Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Dapagliflozin
- Irbesartan
Other Study ID Numbers
- 021IGAN17001
- 2017-004605-41 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Immunoglobulin A Nephropathy
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Everest Medicines (Singapore) Pte. Ltd.Active, not recruitingPrimary Immunoglobulin A Nephropathy (IgAN)China
-
Chinese University of Hong KongWithdrawn
-
Visterra, Inc.CompletedImmunoglobulin A Nephropathy | IgA Nephropathy | IgAN - IgA NephropathyUnited States
-
Baxalta now part of ShireWithdrawnImmunoglobulin A Nephropathy
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BioCryst PharmaceuticalsTerminatedImmunoglobulin A Nephropathy | Membranous Nephropathy | Complement 3 GlomerulopathyFrance, Italy, Spain, United Kingdom
-
Medical University of ViennaCompleted
-
Chinook Therapeutics, Inc.RecruitingImmunoglobulin A Nephropathy | IgA NephropathyUnited States, Canada, Australia, Argentina, Korea, Republic of
-
Keymed Biosciences Co.LtdRecruiting
-
Chinook Therapeutics, Inc.RecruitingImmunoglobulin A Nephropathy | IgA NephropathySpain, Australia, United States
-
HI-BioActive, not recruitingImmunoglobulin A (IgA) NephropathyUnited Kingdom, Germany, Spain, Serbia, Taiwan, Australia, Japan, Korea, Republic of, Belgium, United States, Bulgaria, Czechia, Georgia, Malaysia, Philippines, Ukraine
Clinical Trials on sparsentan
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Travere Therapeutics, Inc.RecruitingImmunoglobulin A NephropathyUnited States, Hong Kong
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Travere Therapeutics, Inc.RecruitingFocal Segmental Glomerulosclerosis | Immunoglobulin A Nephropathy | Minimal Change Disease | Alport Syndrome | IgA VasculitisUnited States, Italy, Netherlands, Poland, Spain, United Kingdom, Germany, Sweden
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University of LeicesterTravere Therapeutics, Inc.Active, not recruitingImmune System Diseases | Autoimmune Diseases | Kidney Diseases | Glomerulonephritis | Immunoglobulin A Nephropathy | Glomerulonephritis, IGAUnited Kingdom
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Travere Therapeutics, Inc.CompletedHealthy SubjectsUnited Kingdom
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Travere Therapeutics, Inc.Active, not recruitingFocal Segmental GlomerulosclerosisUnited States, Italy, Czechia
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University of EdinburghTravere Therapeutics, Inc.RecruitingCardiovascular Diseases | Kidney Diseases | ANCA Associated VasculitisUnited Kingdom
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Travere Therapeutics, Inc.Active, not recruitingFocal Segmental GlomerulosclerosisUnited States, Australia, Belgium, Croatia, Estonia, Germany, Hong Kong, Italy, Korea, Republic of, Poland, Portugal, Spain, Taiwan, United Kingdom, Argentina, Brazil, Canada, Czechia, Denmark, France, New Zealand, Sweden
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Bristol-Myers SquibbCompletedCrohn's DiseasePoland, United States, France, Belgium, Israel, Hungary, South Africa, Puerto Rico
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Eda Cetin OzdemirCompletedPeriodontal DiseasesTurkey
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Julio RamirezUniversity of LouisvilleTerminatedOsteomyelitisUnited States