Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
Primary Purpose
IGA Nephropathy
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fostamatinib Disodium tablet 100 mg
Fostamatinib Disodium tablet 150 mg
Sponsored by
About this trial
This is an interventional treatment trial for IGA Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology)
- Able and willing to give written informed consent
Exclusion Criteria:
- Unresolved Grade 2 or greater toxicity in Study C-935788-050
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fostamatinib Disodium tablet 100 mg
Fostamatinib Disodium tablet 150 mg
Arm Description
Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months
Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months
Outcomes
Primary Outcome Measures
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02433236
Brief Title
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
Official Title
A Phase 2, Multi-Centre, Open Label Extension Study of Fostamatinib in the Treatment of IgA Nephropathy for Patients Who Participated in Study C-935788-050
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn prior to enrollment of first subject
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 2, multi-center, open label extension study to evaluate 2 dose regimens of fostamatinib in approximately 25 subjects. The study will consist of 11 visits over 15 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fostamatinib Disodium tablet 100 mg
Arm Type
Experimental
Arm Description
Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months
Arm Title
Fostamatinib Disodium tablet 150 mg
Arm Type
Experimental
Arm Description
Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months
Intervention Type
Drug
Intervention Name(s)
Fostamatinib Disodium tablet 100 mg
Other Intervention Name(s)
Fostamatinib, R788
Intervention Type
Drug
Intervention Name(s)
Fostamatinib Disodium tablet 150 mg
Other Intervention Name(s)
Fostamatinib, R788
Primary Outcome Measure Information:
Title
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completed Study C-938788-050, including having received a post-treatment renal biopsy, and having had a clinically meaningful response (i.e. decreased proteinuria or improved renal histology)
Able and willing to give written informed consent
Exclusion Criteria:
Unresolved Grade 2 or greater toxicity in Study C-935788-050
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigel Pharmaceuticals, Inc.
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
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