Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
NCT ID: NCT02112838
Last Updated: 2019-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2014-10-31
2018-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
Interventions
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Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
* Proteinuria \> 1 gm/day at diagnosis of IgA nephropathy and Proteinuria \> 0.50 gm/day at the second Screening Visit
* Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents
Exclusion Criteria
* Use of \> 15 mg/day prednisone (or other corticosteroid equivalent).
18 Years
70 Years
ALL
No
Sponsors
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Rigel Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rigel Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
Rigel Pharmaceuticals,Inc.
Locations
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Stanford University Medical
Palo Alto, California, United States
Nephrology Associates PC, University Hospital, Professional Center 1
Augusta, Georgia, United States
Ohio State University
Columbus, Ohio, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Medical University of Graz
Graz, Styria, Austria
Medical University Vienna, Nephrology
Vienna, , Austria
Medical University of Heidelberg
Heidelberg, Baden-Wurtemberberg, Germany
Klinikum der Universität München
Munich, Bavaria, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany
Medical University of Jena
Jena, Thuringia, Germany
Prince of Wales Hospital
Hong Kong, Sha Tin, Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
China Medical University Hospital
Taichung, , Taiwan
School of Medicine, Chang Gung University, Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Addenbrookes Hospital
Cambridge, , United Kingdom
Cardiff University
Cardiff, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Prendecki M, Gulati K, Turner-Stokes T, Bhangal G, Chiappo D, Woollard K, Cook HT, Tam FW, Roufosse C, Pusey CD, McAdoo SP. Characterisation of an enhanced preclinical model of experimental MPO-ANCA autoimmune vasculitis. J Pathol. 2021 Oct;255(2):107-119. doi: 10.1002/path.5746. Epub 2021 Jul 23.
McAdoo S, Tam FWK. Role of the Spleen Tyrosine Kinase Pathway in Driving Inflammation in IgA Nephropathy. Semin Nephrol. 2018 Sep;38(5):496-503. doi: 10.1016/j.semnephrol.2018.05.019.
Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-000331-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C-935788-050
Identifier Type: -
Identifier Source: org_study_id
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