Open Label Study of Fostamatinib in the Treatment of IgA... | NCT02433236

Studies
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

NCT02433236

Sponsor

Rigel Pharmaceuticals

Status

Withdrawn

Last Update Posted

Oct 23, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

IGA Nephropathy

Interventions

Fostamatinib Disodium tablet 100 mg
Fostamatinib Disodium tablet 150 mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn prior to enrollment of first subject

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Not provided

First Submitted Date

Apr 29, 2015

First Submission Date that Met QC Criteria

Apr 29, 2015

First Posted Date

May 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2015

Last Update Posted Date

Oct 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fostamatinib Disodium tablet 100 mg	Drug		Fostamatinib Disodium tablet 100 mg	Fostamatinib R788

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Rigel Pharmaceuticals, Inc.	Rigel Pharmaceuticals,Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D005922	Glomerulonephritis, IGA

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523665	fostamatinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided