Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Phase 2

Withdrawn

• Conditions: IGA Nephropathy
• Interventions: Drug: Fostamatinib Disodium tablet 150 mg; Drug: Fostamatinib Disodium tablet 100 mg

• Registration Number: NCT02433236
• Lead Sponsor: Rigel Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-04
• Study Start: 2015-09
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fostamatinib Disodium tablet 150 mg	Fostamatinib Disodium tablet 150 mg	Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months
Fostamatinib Disodium tablet 100 mg	Fostamatinib Disodium tablet 100 mg	Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months

Primary Outcome Measures

Name	Time	Method
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)	15 months