Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

Sponsor
Rigel Pharmaceuticals
Study ID
NCT02433236
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2015
Status verified
Oct 2015
Primary completion
Sep 30, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fostamatinib Disodium tablet 100 mg
    Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months
  • Experimental: Fostamatinib Disodium tablet 150 mg
    Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months

Primary Outcome Measure

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

Related Studies