Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy

October 21, 2015 updated by: Rigel Pharmaceuticals

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fostamatinib Disodium tablet 100 mg
Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months
Drug: Fostamatinib Disodium tablet 100 mg
Other Names:
  • Fostamatinib
  • R788
Experimental: Fostamatinib Disodium tablet 150 mg
Fostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months
Drug: Fostamatinib Disodium tablet 150 mg
Other Names:
  • Fostamatinib
  • R788

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-935788-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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