Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Rigel Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: IGA Nephropathy

Treatments: Drug: Fostamatinib Disodium tablet 150 mg; Drug: Fostamatinib Disodium tablet 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02433236

C-935788-051

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 72 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Fostamatinib Disodium tablet 100 mg

Experimental group

Description:

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

Treatment:

Drug: Fostamatinib Disodium tablet 100 mg

Fostamatinib Disodium tablet 150 mg

Experimental group

Description:

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

Treatment:

Drug: Fostamatinib Disodium tablet 150 mg