IGA Nephropathy
Conditions
Keywords
IGA Glomerulonephritis, Nephritis, IGA Type
Brief summary
The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of IgA Nephropathy
Interventions
DRUGFostamatinib 150 mg
Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
DRUGFostamatinib 100 mg
Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
DRUGPlacebo
Placebo tablet twice daily by mouth, over the course of 24 weeks
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 ≥50% reduction in sPCR from Baseline (Visit 2) at Week 24 (Visit 9) |
| Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | Baseline to Week 24 | Percentage of subjects with ≥ 30% reduction in proteinuria from Baseline (Visit 2) at 24 weeks (Visit 9). |
| 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 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. |
| Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. | 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. |
| Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. | 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. |
| Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. | 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. |
| Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | 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. |
| Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). | Baseline to Week 12 | Mean change from Baseline (Visit 2) of eGFR at 12 weeks (Visit 7). |
| Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9). | Baseline to Week 24 | Mean change from Baseline (Visit 2) of eGFR at 24 weeks (Visit 9). |
| Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). | Baseline to Week 12 | Mean change from Baseline (Visit 2) of proteinuria at 12 weeks (Visit 7). |
| Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7). | Baseline to Week 12 | Percentage of subjects with sPCR \<50 mg/mmol (500 mg/g) at 12 weeks (Visit 7). |
| Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Baseline to Week 12 | Shift in haematuria (dipstick test) from Baseline (Visit 2) at 12 weeks (Visit 7). |
| Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Baseline to Week 24 | Shift in haematuria (dipstick test) from Baseline (Visit 2) at 24 weeks (Visit 9). |
| Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. | 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. |
Countries
Austria, Germany, Hong Kong, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| 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 | 26 |
| 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 | 25 |
| Total | 76 |
Baseline characteristics
| Characteristic | Fostamatinib 150 mg | Fostamatinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 25 Participants | 25 Participants | 72 Participants |
| Age, Continuous | 43.1 years STANDARD_DEVIATION 14.8 | 42.3 years STANDARD_DEVIATION 14.1 | 40.6 years STANDARD_DEVIATION 11.6 | 42.0 years STANDARD_DEVIATION 40.5 |
| Race (NIH/OMB) American Indian or Alaska Native | NA Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Asian | 11 Participants | 6 Participants | 6 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | NA Participants | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) White | 13 Participants | 19 Participants | 19 Participants | 51 Participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 24 / 25 | 22 / 26 | 21 / 25 |
| serious Total, serious adverse events | 2 / 25 | 2 / 26 | 2 / 25 |
Outcome results
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
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | -157.5 mg/g | Standard Error 345.6 |
| Fostamatinib 100 mg | Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | -577.2 mg/g | Standard Error 335.7 |
| Placebo | Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | -177.4 mg/g | Standard Error 342.4 |
p-value: 0.9795% CI: [-910.6, 950.5]ANCOVA
p-value: 0.495% CI: [-1320.8, 521.3]ANCOVA
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).
Time frame: Baseline to Week 12
Population: Analysis population includes only subjects who completed visits through Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). | -2.0 eGFR (mL/min/1.73 m2) | Standard Error 2.1 |
| Fostamatinib 100 mg | Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). | 2.1 eGFR (mL/min/1.73 m2) | Standard Error 1.9 |
| Placebo | Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). | 1.4 eGFR (mL/min/1.73 m2) | Standard Error 2 |
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).
Time frame: Baseline to Week 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9). | -0.9 eGFR (mL/min/1.73 m2) | Standard Error 1.9 |
| Fostamatinib 100 mg | Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9). | 2.0 eGFR (mL/min/1.73 m2) | Standard Error 1.8 |
| Placebo | Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9). | -0.2 eGFR (mL/min/1.73 m2) | Standard Error 1.8 |
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).
Time frame: Baseline to Week 12
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). | -293.1 mg/g | Standard Error 202 |
| Fostamatinib 100 mg | Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). | -529.2 mg/g | Standard Error 196.4 |
| Placebo | Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7). | -328.3 mg/g | Standard Error 199.9 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | -0.3 mesangial hypercellularity score | Standard Error 1.6 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | -0.2 mesangial hypercellularity score | Standard Error 0.1 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | -0.1 mesangial hypercellularity score | Standard Error 0.1 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. | 2.3 Percentage of glomeruli | Standard Error 1.6 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. | -1.5 Percentage of glomeruli | Standard Error 0.8 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. | -0.4 Percentage of glomeruli | Standard Error 0.8 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies. | -3.1 Percentage of glomeruli | Standard Error 3.2 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies. | -4.0 Percentage of glomeruli | Standard Error 1.5 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies. | -5.4 Percentage of glomeruli | Standard Error 1.7 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. | -11.9 Percentage of glomeruli | Standard Error 10.1 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. | 8.34 Percentage of glomeruli | Standard Error 4.8 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. | 0.5 Percentage of glomeruli | Standard Error 5.2 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. | -4.4 Percentage of glomeruli | Standard Error 7.8 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. | -6.8 Percentage of glomeruli | Standard Error 3.6 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. | -0.8 Percentage of glomeruli | Standard Error 3.9 |
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.
Time frame: Baseline to Week 24
Population: Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Fostamatinib 150 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. | -7.4 Percentage of glomeruli | Standard Error 9.7 |
| Fostamatinib 100 mg | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. | 4.4 Percentage of glomeruli | Standard Error 4.6 |
| Placebo | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. | -1.7 Percentage of glomeruli | Standard Error 5 |
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).
Time frame: Baseline to Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib 150 mg | Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | 8 Participants |
| Fostamatinib 100 mg | Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | 12 Participants |
| Placebo | Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | 8 Participants |
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)
Time frame: Baseline to Week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib 150 mg | Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | 5 Participants |
| Fostamatinib 100 mg | Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | 8 Participants |
| Placebo | Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | 4 Participants |
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).
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fostamatinib 150 mg | Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7). | 9 percentage of subjects |
| Fostamatinib 100 mg | Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7). | 16 percentage of subjects |
| Placebo | Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7). | 12 percentage of subjects |
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).
Time frame: Baseline to Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Same/Unchanged | 13 subjects |
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Increased | 1 subjects |
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Decreased | 8 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Same/Unchanged | 21 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Increased | 0 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Decreased | 4 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Increased | 0 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Decreased | 4 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7). | Same/Unchanged | 21 subjects |
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).
Time frame: Baseline to Week 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Same/Unchanged | 14 subjects |
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Increased | 1 subjects |
| Fostamatinib 150 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Decreased | 6 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Same/Unchanged | 15 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Increased | 1 subjects |
| Fostamatinib 100 mg | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Decreased | 8 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Increased | 0 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Decreased | 5 subjects |
| Placebo | Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9). | Same/Unchanged | 19 subjects |