We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112838
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy

Condition or disease Intervention/treatment Phase
IGA Nephropathy Drug: Fostamatinib 150 mg Drug: Fostamatinib 100 mg Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : March 23, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
 Drug: Fostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
Other Names:
  • R935788
  • R788
Active Comparator: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
 Drug: Fostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
Other Names:
  • R935788
  • R788
Placebo Comparator: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
 Drug: Placebo
Placebo tablet twice daily by mouth, over the course of 24 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. [ Time Frame: Baseline to Week 24 ]

    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.


  2. 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 ≥50% reduction in sPCR from Baseline (Visit 2) at Week 24 (Visit 9)

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

  4. 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 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.


  5. 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 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.


  6. 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 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.


  7. 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 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.


  8. 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 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.

  9. 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 12 weeks (Visit 7).

  10. 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 eGFR at 24 weeks (Visit 9).

  11. Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). [ Time Frame: Baseline to Week 12 ]
    Mean change from Baseline (Visit 2) of proteinuria at 12 weeks (Visit 7).

  12. Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) 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).

  13. 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 12 weeks (Visit 7).

  14. Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). [ Time Frame: Baseline to Week 24 ]
    Shift in haematuria (dipstick test) from Baseline (Visit 2) at 24 weeks (Visit 9).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.
  • Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112838


Locations
Show Show 20 study locations
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Rigel Pharmaceuticals, Inc. Rigel Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Rigel Pharmaceuticals:
Study Protocol  [PDF] March 17, 2017
Statistical Analysis Plan  [PDF] March 22, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02112838    
Other Study ID Numbers: C-935788-050
2014-000331-16 ( EudraCT Number )
First Posted: April 14, 2014    Key Record Dates
Results First Posted: June 27, 2019
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rigel Pharmaceuticals:
IGA Glomerulonephritis
Nephritis, IGA Type
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases