Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT02433236
• Date of registration: 29/04/2015
• Prospective Registration: Yes
• Primary sponsor: Rigel Pharmaceuticals
• Public title: Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
• Scientific 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
• Date of first enrolment: September 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02433236
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Rigel Pharmaceuticals, Inc.
• Affiliation: Rigel Pharmaceuticals, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 72 Years
Gender: Both

Health Condition(s) or Problem(s) studied

IGA Nephropathy

Intervention(s)

Drug: Fostamatinib Disodium tablet 150 mg

Drug: Fostamatinib Disodium tablet 100 mg

Primary Outcome(s)

Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR) [Time Frame: 15 months]

Secondary ID(s)

C-935788-051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors