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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn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• Status: Withdrawn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. 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

• Glomerulonephritis, IGA
• IGA Nephropathy
• Kidney Diseases

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