NCT02433236

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

April 29, 2015

Last Update Submit

October 21, 2015

Conditions

IGA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)

    15 months

Study Arms (2)

Fostamatinib Disodium tablet 100 mg

EXPERIMENTAL

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

Drug: Fostamatinib Disodium tablet 100 mg

Fostamatinib Disodium tablet 150 mg

EXPERIMENTAL

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

Drug: Fostamatinib Disodium tablet 150 mg

Interventions

Fostamatinib Disodium tablet 100 mgDRUG
Also known as: Fostamatinib, R788
Fostamatinib Disodium tablet 100 mg
Fostamatinib Disodium tablet 150 mgDRUG
Also known as: Fostamatinib, R788
Fostamatinib Disodium tablet 150 mg

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unresolved Grade 2 or greater toxicity in Study C-935788-050

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rigel Pharmaceuticals, Inc.

    Rigel Pharmaceuticals,Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2015

Last Updated

October 23, 2015

Record last verified: 2015-10