Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02112838 |
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Recruitment Status :
Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : June 25, 2018
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Sponsor:
Rigel Pharmaceuticals
Information provided by (Responsible Party):
Rigel Pharmaceuticals
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Brief Summary:
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| IGA Nephropathy | Drug: Fostamatinib 150 mg Drug: Fostamatinib 100 mg Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy |
| Study Start Date : | October 2014 |
| Actual Primary Completion Date : | March 23, 2018 |
| Estimated Study Completion Date : | December 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
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Drug: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Other Names:
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Active Comparator: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
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Drug: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Other Names:
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Placebo Comparator: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
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Drug: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks |
Primary Outcome Measures :
- Mean change of proteinuria as measured by spot urine protein/creatinine ratio (sPCR) [ Time Frame: Baseline to 24 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Renal biopsy findings consistent with IgA nephropathy
- 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:
- Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
- Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112838
Locations
| United States, California | |
| Stanford University Medical | |
| Palo Alto, California, United States, 94304 | |
| United States, Georgia | |
| Nephrology Associates PC, University Hospital, Professional Center 1 | |
| Augusta, Georgia, United States, 30901 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Tennessee | |
| Southeast Renal Research Institute | |
| Chattanooga, Tennessee, United States, 37408 | |
| Austria | |
| Medical University of Graz | |
| Graz, Steiermark, Austria, 8036 | |
| Medical University Vienna, Nephrology | |
| Vienna, Austria, A-1090 | |
| Germany | |
| Medical University of Heidelberg | |
| Heidelberg, Baden-Wurtemberberg, Germany, 69120 | |
| Klinikum der Universität München | |
| Munich, Bayern, Germany, 80336 | |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | |
| Dresden, Sachsen, Germany, 1307 | |
| Medical University of Jena | |
| Jena, Thueringen, Germany, 07747 | |
| Hong Kong | |
| Prince of Wales Hospital | |
| Hong Kong, Sha Tin, Hong Kong | |
| Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
| Taiwan | |
| China Medical University Hospital | |
| Taichung, Taiwan, 40447 | |
| School of Medicine, Chang Gung University, Chang Gung Memorial Hospital | |
| Taoyuan, Taiwan, 333 | |
| United Kingdom | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Cardiff University | |
| Cardiff, United Kingdom, CF14 4XN | |
| Leicester General Hospital | |
| Leicester, United Kingdom, LE5 4PW | |
| Royal Free Hospital | |
| London, United Kingdom, NW3 2PF | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Freeman Hospital | |
| Newcastle upon Tyne, United Kingdom, NE7 7DN | |
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
| Study Director: | Rigel Pharmaceuticals, Inc. | Rigel Pharmaceuticals, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rigel Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02112838 History of Changes |
| Other Study ID Numbers: |
C-935788-050 2014-000331-16 ( EudraCT Number ) |
| First Posted: | April 14, 2014 Key Record Dates |
| Last Update Posted: | June 25, 2018 |
| Last Verified: | June 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Rigel Pharmaceuticals:
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IGA Glomerulonephritis Nephritis, IGA Type |
Additional relevant MeSH terms:
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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |