Phase 2
N=76
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
IGA Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT02112838 ↗Enrolled (actual)
76
Serious AEs
7.9%
Results posted
Jun 2019
Primary outcome: Primary: Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 — -157.5; -577.2; -177.4 mg/g — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fostamatinib 150 mg (Drug); Fostamatinib 100 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigel Pharmaceuticals
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 |
-157.5; -577.2; -177.4 | 0.97 |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. |
-0.3; -0.2; -0.1 | — |
| SECONDARY Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). |
5; 8; 4 | — |
| SECONDARY Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). |
8; 12; 8 | — |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies. |
-3.1; -4.0; -5.4 | — |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. |
-4.4; -6.8; -0.8 | — |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. |
-11.9; 8.34; 0.5 | — |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. |
-7.4; 4.4; -1.7 | — |
| SECONDARY Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. |
2.3; -1.5; -0.4 | — |
| SECONDARY Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). |
-2.0; 2.1; 1.4 | — |
| SECONDARY Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9). |
-0.9; 2.0; -0.2 | — |
| SECONDARY Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). |
-293.1; -529.2; -328.3 | — |
| SECONDARY Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7). |
9; 16; 12 | — |
| SECONDARY Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). |
1; 0; 0; 13; 21; 21 | — |
| SECONDARY Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). |
1; 1; 0; 14; 15; 19 | — |
Summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT02112838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.