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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Withdrawn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
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IGA Nephropathy

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 29, 2015
    Last Updated
    October 21, 2015
    Sponsor
    Rigel Pharmaceuticals
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    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    Withdrawn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    Study withdrawn prior to enrollment of first subject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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