Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Rigel Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

IGA Nephropathy

Interventions

Fostamatinib Disodium tablet 100 mgDRUG

Fostamatinib Disodium tablet 150 mgDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)

Time frame: 15 months

Data from ClinicalTrials.gov

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