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Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

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ClinicalTrials.gov Identifier: NCT02112838
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

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
Active Comparator: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Drug: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Other Names:
  • R935788
  • R788

Active Comparator: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Drug: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Other Names:
  • R935788
  • R788

Placebo Comparator: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
Drug: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks




Primary Outcome Measures :
  1. Mean change of proteinuria as measured by spot urine protein/creatinine ratio (sPCR) [ Time Frame: Baseline to 24 weeks ]


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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:
IGA Glomerulonephritis
Nephritis, IGA Type

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases