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Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02433236
Enrollment
0
Registered
2015-05-04
Start date
2015-09-30
Completion date
Unknown
Last updated
2015-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IGA Nephropathy

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.

Interventions

DRUGFostamatinib Disodium tablet 100 mg
DRUGFostamatinib Disodium tablet 150 mg

Sponsors

Rigel Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026