Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

Rigel Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: IGA Nephropathy

Treatments: Drug: Placebo; Drug: Fostamatinib 150 mg; Drug: Fostamatinib 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112838

2014-000331-16 (EudraCT Number)

C-935788-050

Details and patient eligibility

About

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renal biopsy findings consistent with IgA nephropathy
• Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
• Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
• Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Exclusion criteria

• Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
• Use of > 15 mg/day prednisone (or other corticosteroid equivalent).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 3 patient groups, including a placebo group

Fostamatinib 150 mg

Active Comparator group

Description:

Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks

Treatment:

Drug: Fostamatinib 150 mg

Fostamatinib 100 mg

Active Comparator group

Description:

Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks

Treatment:

Drug: Fostamatinib 100 mg

Placebo

Placebo Comparator group

Description:

Placebo tablet twice daily by mouth, over the course of 24 weeks

Treatment:

Drug: Placebo