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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02112838
• Date of registration: 10/04/2014
• Prospective Registration: Yes
• Primary sponsor: Rigel Pharmaceuticals
• Public title: Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02112838
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Austria, Germany, Hong Kong, Singapore, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Rigel Pharmaceuticals, Inc.
• Affiliation: Rigel Pharmaceuticals, Inc.

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

IGA Nephropathy

Intervention(s)

Drug: Fostamatinib 100 mg

Drug: Fostamatinib 150 mg

Drug: Placebo

Primary Outcome(s)

Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 [Time Frame: Baseline to 24 weeks]

Secondary Outcome(s)

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 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]

Percentage of Subjects With =50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (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]

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]

Percentage of Subjects With = 30% Reduction in Proteinuria 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). [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 Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. [Time Frame: Baseline to Week 24]

Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) 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]

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 Segmental Sclerosis/Adhesion (S) on Renal Biopsies. [Time Frame: Baseline to Week 24]

Secondary ID(s)

2014-000331-16

C-935788-050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02112838