Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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IGA Nephropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fostamatinib Disodium tablet 100 mg

Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months

Group Type EXPERIMENTAL

Fostamatinib Disodium tablet 100 mg

Intervention Type DRUG

Fostamatinib Disodium tablet 150 mg

Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months

Group Type EXPERIMENTAL

Fostamatinib Disodium tablet 150 mg

Intervention Type DRUG

Interventions

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Fostamatinib Disodium tablet 100 mg

Intervention Type DRUG

Fostamatinib Disodium tablet 150 mg

Intervention Type DRUG

Other Intervention Names

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Fostamatinib R788 Fostamatinib R788

Eligibility Criteria

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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