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NCT02433236 Clinical Trial

Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

IGA Nephropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02433236
Other study ID # C-935788-051
Secondary ID
Status Withdrawn
Phase Phase 2
First received April 29, 2015
Last updated October 21, 2015
Start date September 2015

Study information
Verified date October 2015
Source Rigel Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthSingapore: Health Sciences AuthoritySwitzerland: SwissmedicTaiwan : Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 72 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Fostamatinib Disodium tablet 100 mg

• Fostamatinib Disodium tablet 150 mg

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rigel Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR) 15 months No
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