IGA NephropathyPhase 2NCT02112838

Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy

A Phase 2 study testing Fostamatinib 150 mg and Fostamatinib 100 mg in people with IGA Nephropathy, run by Rigel Pharmaceuticals at 20 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: IGA Nephropathy
What is being tested?: Fostamatinib 150 mg and Fostamatinib 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 20 sitesin 6 countries
Study dates: Oct 2014to 12 Nov 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Renal biopsy findings consistent with IgA nephropathy
Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Who cannot join

Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
Use of > 15 mg/day prednisone (or other corticosteroid equivalent).

Trial locations and contacts

20 sites in 6 countries.

Country

City, postcode or hospital

20 sites in 6 countries

United Kingdom6 sites

Addenbrookes Hospital
Cambridge, CB2 0QQ
Cardiff University
Cardiff, CF14 4XN
Leicester General Hospital
Leicester, LE5 4PW
Royal Free Hospital
London, NW3 2PF
Hammersmith Hospital
London, W12 0NN
Freeman Hospital
Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

United States4 sites

Nephrology Associates PC, University Hospital, Professional Center 1
Augusta, Georgia, 30901
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
Ohio State University
Columbus, Ohio, 43210
Stanford University Medical
Palo Alto, California, 94304

Other trials in United States

Germany4 sites

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 1307
Medical University of Heidelberg
Heidelberg, Baden-Wurtemberberg, 69120
Medical University of Jena
Jena, Thuringia, 07747
Klinikum der Universität München
Munich, Bavaria, 80336

Other trials in Germany

Austria2 sites

Medical University of Graz
Graz, Styria, 8036
Medical University Vienna, Nephrology
Vienna, A-1090

Other trials in Austria

Hong Kong2 sites

Prince of Wales Hospital
Hong Kong, Sha Tin
Queen Mary Hospital
Hong Kong

Other trials in Hong Kong

Taiwan2 sites

China Medical University Hospital
Taichung, 40447
School of Medicine, Chang Gung University, Chang Gung Memorial Hospital
Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

Conditions: IGA Nephropathy
Being tested: Fostamatinib 150 mg, Fostamatinib 100 mg, Placebo
Keywords: IGA Glomerulonephritis, Nephritis, IGA Type
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 150 mgDrug
Also called R935788, R788
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 100 mgDrug
Also called R935788, R788
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
PlaceboDrug
Placebo tablet twice daily by mouth, over the course of 24 weeks

Study groups in NCT02112838
Study group	Role	What they receive
Fostamatinib 150 mg	Active comparator	Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Receives: Drug: Fostamatinib 150 mg
Fostamatinib 100 mg	Active comparator	Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Receives: Drug: Fostamatinib 100 mg
Placebo	Placebo comparator	Placebo tablet twice daily by mouth, over the course of 24 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24
Mean change from Baseline (Visit 2) of proteinuria as measured by the spot Protein-Creatinine Ratio (sPCR) at 24 weeks (Visit 9) for the ITT Population
Measured: Baseline to 24 weeks

Secondary outcomes (14)

Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.
Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.
M = the mean score based on Oxford Classification system score is based on total count of mesangial cells for all glomeruli (count of <4=0 score, 4 to 5=1, 6 to 7=2, ≥8=3). A decrease in score equates to improvement from IgAN disease.
Measured: Baseline to Week 24
Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9).
Percentage of subjects with ≥50% reduction in sPCR from Baseline (Visit 2) at Week 24 (Visit 9)
Measured: Baseline to Week 24
Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9).
Percentage of subjects with ≥ 30% reduction in proteinuria from Baseline (Visit 2) at 24 weeks (Visit 9).
Measured: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies.
Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.
E = Percentage of glomeruli eypercellularity due to increased number of cells within glomerular capillary lumina causing narrowing of the lumina. A decrease in score equates to improvement from IgAN disease.
Measured: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies.
Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.
S = Percentage of any amount of the tuft involved in sclerosis, but not involving the whole tuft or the presence of an adhesion in each glomeruli. A decrease in score equates to improvement from IgAN disease.
Measured: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies.
Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.
Percentage of any amount of the tuft involved in sclerosis, but not involving the whole tuft or the presence of an adhesion in each glomeruli. A decrease in score equates to improvement from IgAN disease.
Measured: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies.
Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.
T= Percentage of cortical area involved by the tubular atrophy or interstitial fibrosis, whichever is greater. A decrease in score equates to improvement from IgAN disease.
Measured: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies.
Mean change from pre-treatment to post-treatment in cellular/fibrocellular crescent score on renal biopsies. Biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored using the Oxford Classification of IgA nepthropathy (IgAN) system for assessing histologic findings in IgAN.
Measured: Baseline to Week 24
Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7).
Mean change from Baseline (Visit 2) of eGFR at 12 weeks (Visit 7).
Measured: Baseline to Week 12
Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9).
Mean change from Baseline (Visit 2) of eGFR at 24 weeks (Visit 9).
Measured: Baseline to Week 24
Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7).
Mean change from Baseline (Visit 2) of proteinuria at 12 weeks (Visit 7).
Measured: Baseline to Week 12
Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7).
Percentage of subjects with sPCR <50 mg/mmol (500 mg/g) at 12 weeks (Visit 7).
Measured: Baseline to Week 12
Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7).
Shift in haematuria (dipstick test) from Baseline (Visit 2) at 12 weeks (Visit 7).
Measured: Baseline to Week 12
Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9).
Shift in haematuria (dipstick test) from Baseline (Visit 2) at 24 weeks (Visit 9).
Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201412 Nov 2018

First posted14 Apr 2014 (estimated)
Study startOct 2014
Primary completion23 Mar 2018
Study completion12 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02112838
Sponsor's protocol ID: C-935788-050
Other IDs: 2014-000331-16, 2014
Status last verified: Jun 2019
First submitted: 10 Apr 2014
Last updated: 27 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Prendecki M, Gulati K, Turner-Stokes T, Bhangal G, Chiappo D, Woollard K, Cook HT, Tam FW, Roufosse C, Pusey CD, McAdoo SP. Characterisation of an enhanced preclinical model of experimental MPO-ANCA autoimmune vasculitis. J Pathol. 2021 Oct;255(2):107-119. doi: 10.1002/path.5746. Epub 2021 Jul 23.
PubMed 34124781
McAdoo S, Tam FWK. Role of the Spleen Tyrosine Kinase Pathway in Driving Inflammation in IgA Nephropathy. Semin Nephrol. 2018 Sep;38(5):496-503. doi: 10.1016/j.semnephrol.2018.05.019.
PubMed 30177021
Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
PubMed 26032537

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IGA Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy
ClinicalTrials.gov ID: NCT02112838
Acronym / sponsor ID: C-935788-050
Conditions: IGA Nephropathy
Keywords: IGA Glomerulonephritis, Nephritis, IGA Type
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: 23 Mar 2018 (actual)
Study completion: 12 Nov 2018 (actual)
First posted: 14 Apr 2014 (estimated)
Results: Posted 27 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Fostamatinib 150 mg	Active comparator	Drug: Fostamatinib 150 mgFostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Fostamatinib 100 mg	Active comparator	Drug: Fostamatinib 100 mgFostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet twice daily by mouth, over the course of 24 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Renal biopsy findings consistent with IgA nephropathy
Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated) dose
Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day at the second Screening Visit
Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents

Key exclusion criteria (2 listed)

Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
Use of > 15 mg/day prednisone (or other corticosteroid equivalent).

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 150 mgAlso: R935788, R788Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks	Drug	Fostamatinib 150 mg
Fostamatinib 100 mgAlso: R935788, R788Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks	Drug	Fostamatinib 100 mg
PlaceboPlacebo tablet twice daily by mouth, over the course of 24 weeks	Drug	Placebo

Primary outcome

Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24
Time frame: Baseline to 24 weeks
Mean change from Baseline (Visit 2) of proteinuria as measured by the spot Protein-Creatinine Ratio (sPCR) at 24 weeks (Visit 9) for the ITT Population

14 secondary outcomes

Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.
Time frame: Baseline to Week 24
Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9).
Time frame: Baseline to Week 24
Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9).
Time frame: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies.
Time frame: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies.
Time frame: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies.
Time frame: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies.
Time frame: Baseline to Week 24
Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies.
Time frame: Baseline to Week 24
Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7).
Time frame: Baseline to Week 12
Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9).
Time frame: Baseline to Week 24
Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7).
Time frame: Baseline to Week 12
Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7).
Time frame: Baseline to Week 12
Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7).
Time frame: Baseline to Week 12
Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9).
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 27 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fostamatinib 150 mg	25	20
Fostamatinib 100 mg	26	24
Placebo	25	24

Primary outcome: Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24

Time frame: Baseline to 24 weeks. Least squares mean (Standard Error). Unit: mg/g

Measure	Fostamatinib 150 mg n = 25	Fostamatinib 100 mg n = 26	Placebo n = 25
Value	-157.5 (345.6)	-577.2 (335.7)	-177.4 (342.4)

Fostamatinib 150 mg vs Placebo: Mean Difference (Final Values): 19.9 (95% CI -910.6 to 950.5), p = 0.97, ANCOVA
Fostamatinib 100 mg vs Placebo: Mean Difference (Final Values): -399.7 (95% CI -1320.8 to 521.3), p = 0.40, ANCOVA

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: The AE reporting period begins with the first dose of study drug and ends with the final study (follow-up) visit. AEs that occur between the time of consent and first dose of study drug will be reported as Medical History. If an SAE is present at the follow-up visit (Week 26, Visit 10) or final visit for subjects receiving extended treatment it was followed to resolution or stabilization unless the subject is lost to follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fostamatinib 150 mg	2 of 25 (8%)	24 of 25 (96%)	1 of 25
Fostamatinib 100 mg	2 of 26 (7.7%)	22 of 26 (84.6%)	0 of 26
Placebo	2 of 25 (8%)	21 of 25 (84%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34124781Prendecki M, Gulati K, Turner-Stokes T, Bhangal G, Chiappo D, Woollard K, Cook HT, Tam FW, Roufosse C, Pusey CD, McAdoo SP. Characterisation of an enhanced preclinical model of experimental MPO-ANCA autoimmune vasculitis. J Pathol. 2021 Oct;255(2):107-119. doi: 10.1002/path.5746. Epub 2021 Jul 23.
Derived from this study: PubMed 30177021McAdoo S, Tam FWK. Role of the Spleen Tyrosine Kinase Pathway in Driving Inflammation in IgA Nephropathy. Semin Nephrol. 2018 Sep;38(5):496-503. doi: 10.1016/j.semnephrol.2018.05.019.
Derived from this study: PubMed 26032537Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Individual participant dataSharing planned: No

Related trials for IGA Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
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.

20 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fostamatinib 150 mg and Fostamatinib 100 mg in people with IGA Nephropathy, run by Rigel Pharmaceuticals at 20 sites in 6 countries.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United Kingdom, United States, Germany, Austria, Hong Kong and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112838, which also lists 3 linked publications.

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 27 Jun 2019.