IGA NephropathyPhase 2NCT02433236
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
A Phase 2 study testing Fostamatinib Disodium tablet 100 mg and Fostamatinib Disodium tablet 150 mg in people with IGA Nephropathy, run by Rigel Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- Fostamatinib Disodium tablet 100 mg and Fostamatinib Disodium tablet 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unresolved Grade 2 or greater toxicity in Study C-935788-050
About this study
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
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.
- Conditions
- IGA Nephropathy
- Being tested
- Fostamatinib Disodium tablet 100 mg, Fostamatinib Disodium tablet 150 mg
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib Disodium tablet 100 mgDrug
Also called Fostamatinib, R788
Fostamatinib Disodium tablet 150 mgDrug
Also called Fostamatinib, R788
| Study group | Role | What they receive |
|---|---|---|
| Fostamatinib Disodium tablet 100 mg | Experimental | Fostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months Receives: 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 Receives: Drug: Fostamatinib Disodium tablet 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2015
Why it stopped: Study withdrawn prior to enrollment of first subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rigel Pharmaceuticals, Inc., Study director, Rigel Pharmaceuticals,Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433236
- Sponsor's protocol ID
- C-935788-051
- Status last verified
- Oct 2015
- First submitted
- 29 Apr 2015
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02433236
- Acronym / sponsor ID
- C-935788-051
- Conditions
- IGA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment of first subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib Disodium tablet 100 mg | Experimental | Drug: Fostamatinib Disodium tablet 100 mgFostamatinib Disodium tablet 100 milligram (mg) by mouth twice a day for 15 months |
| Fostamatinib Disodium tablet 150 mg | Experimental | Drug: Fostamatinib Disodium tablet 150 mgFostamatinib Disodium tablet 150 milligram (mg) by mouth twice a day for 15 months |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unresolved Grade 2 or greater toxicity in Study C-935788-050
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib Disodium tablet 100 mgAlso: Fostamatinib, R788 | Drug | Fostamatinib Disodium tablet 100 mg |
| Fostamatinib Disodium tablet 150 mgAlso: Fostamatinib, R788 | Drug | Fostamatinib Disodium tablet 150 mg |
Primary outcome
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR)
Time frame: 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
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MYTP01 for Immune-Mediated Diseases
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Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
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A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rigel Pharmaceuticals, Inc. study director
Rigel Pharmaceuticals,Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib Disodium tablet 100 mg and Fostamatinib Disodium tablet 150 mg in people with IGA Nephropathy, run by Rigel Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with mean change of Proteinuria as measured by spot urine protein/creatinine ratio (sPCR) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.