| Primary | 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 | | Posted | | Least Squares Mean | Standard Error | mg/g | | Baseline to 24 weeks | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-157.5± 345.6
- OG001-577.2± 335.7
- OG002-177.4± 342.4
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | 0.97 | | Mean Difference (Final Values) | 19.9 | | | 2-Sided | 95 | -910.6 | 950.5 | | | | | Superiority | | | | | ANCOVA | | 0.40 | |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | mesangial hypercellularity score | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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) | | Posted | | Count of Participants | | Participants | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Count of Participants | | Participants | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | Percentage of glomeruli | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | Percentage of glomeruli | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | Percentage of glomeruli | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | Percentage of glomeruli | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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. | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Posted | | Least Squares Mean | Standard Error | Percentage of glomeruli | | Baseline to Week 24 | renal biopsy samples | renal biopsy samples | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | |
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| Secondary | 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). | Analysis population includes only subjects who completed visits through Week 12. | Posted | | Least Squares Mean | Standard Error | eGFR (mL/min/1.73 m2) | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Least Squares Mean | Standard Error | eGFR (mL/min/1.73 m2) | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Least Squares Mean | Standard Error | mg/g | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Number | | percentage of subjects | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Number | | subjects | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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| Secondary | 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). | | Posted | | Number | | subjects | | Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Fostamatinib 150 mg | Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 150 mg: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks | | OG001 | Fostamatinib 100 mg | Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks Fostamatinib 100 mg: Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks | | OG002 | Placebo | Placebo tablet twice daily by mouth, over the course of 24 weeks Placebo: Placebo tablet twice daily by mouth, over the course of 24 weeks |
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