NCT02112838

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Typical duration for phase_2

Geographic Reach
6 countries

20 active sites

Status
completed

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 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 27, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3.5 years

First QC Date

April 10, 2014

Results QC Date

March 21, 2019

Last Update Submit

June 10, 2019

Conditions

IGA Nephropathy

Keywords

IGA GlomerulonephritisNephritis, IGA Type

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to 24 weeks

Secondary Outcomes (14)

  • Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.

    Baseline to Week 24

  • Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9).

    Baseline to Week 24

  • Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9).

    Baseline to Week 24

  • Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies.

    Baseline to Week 24

  • Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies.

    Baseline to Week 24

  • +9 more secondary outcomes

Study Arms (3)

Fostamatinib 150 mg

ACTIVE COMPARATOR

Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks

Drug: Fostamatinib 150 mg

Fostamatinib 100 mg

ACTIVE COMPARATOR

Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks

Drug: Fostamatinib 100 mg

Placebo

PLACEBO COMPARATOR

Placebo tablet twice daily by mouth, over the course of 24 weeks

Drug: Placebo

Interventions

Fostamatinib 150 mgDRUG

Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks

Also known as: R935788, R788
Fostamatinib 150 mg
Fostamatinib 100 mgDRUG

Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks

Also known as: R935788, R788
Fostamatinib 100 mg
PlaceboDRUG

Placebo tablet twice daily by mouth, over the course of 24 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Stanford University Medical

Palo Alto, California, 94304, United States

Location

Nephrology Associates PC, University Hospital, Professional Center 1

Augusta, Georgia, 30901, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37408, United States

Location

Medical University of Graz

Graz, Styria, 8036, Austria

Location

Medical University Vienna, Nephrology

Vienna, A-1090, Austria

Location

Medical University of Heidelberg

Heidelberg, Baden-Wurtemberberg, 69120, Germany

Location

Klinikum der Universität München

Munich, Bavaria, 80336, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, 1307, Germany

Location

Medical University of Jena

Jena, Thuringia, 07747, Germany

Location

Prince of Wales Hospital

Hong Kong, Sha Tin, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

School of Medicine, Chang Gung University, Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

Leicester General Hospital

Leicester, LE5 4PW, United Kingdom

Location

Royal Free Hospital

London, NW3 2PF, United Kingdom

Location

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 34124781DERIVED

  • 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.

    PMID: 30177021DERIVED

  • 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.

    PMID: 26032537DERIVED

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

Results Point of Contact

Title
Sandra Tong
Organization
Rigel Pharmaceuticals
stong@rigel.com
1-650-624-1207

Study Officials

  • Rigel Pharmaceuticals, Inc.

    Rigel Pharmaceuticals,Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

October 1, 2014

Primary Completion

March 23, 2018

Study Completion

November 12, 2018

Last Updated

June 27, 2019

Results First Posted

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)AU(2)DE(4)TW(2)GB(6)US(4)