Trial · NCT02112838
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
NCT02112838, Phase 2, Completed, Rigel Pharmaceuticals; results first posted 2019-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy. Trials, record NCT02112838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02112838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
- NCT number
- NCT02112838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Rigel Pharmaceuticals
- Conditions
- IGA Nephropathy
- Interventions
- Fostamatinib 150 mg, Fostamatinib 100 mg, Placebo
- First posted
- 2014-04-14
- Last updated
- 2019-06-27
- Other registries' IDs
- eudract:2014-000331-16
- Results first posted
- 2019-06-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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) |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | Baseline to 24 weeks | mg/g | LEAST_SQUARES_MEAN | |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | mesangial hypercellularity score | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | Baseline to Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Percentage of glomeruli | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Percentage of glomeruli | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Percentage of glomeruli | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Percentage of glomeruli | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies. | Baseline to Week 24 | Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected. | Percentage of glomeruli | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7). | Baseline to Week 12 | Analysis population includes only subjects who completed visits through Week 12. | eGFR (mL/min/1.73 m2) | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | Fostamatinib 150 mg | -157.5 | Standard Error 345.6 | mg/g | |
| Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | Fostamatinib 100 mg | -577.2 | Standard Error 335.7 | mg/g | |
| Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24 | Placebo | -177.4 | Standard Error 342.4 | mg/g | |
| Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | Fostamatinib 150 mg | -0.3 | Standard Error 1.6 | mesangial hypercellularity score | |
| Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | Fostamatinib 100 mg | -0.2 | Standard Error 0.1 | mesangial hypercellularity score | |
| Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies. | Placebo | -0.1 | Standard Error 0.1 | mesangial hypercellularity score | |
| Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | Fostamatinib 150 mg | 5 | Participants | ||
| Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | Fostamatinib 100 mg | 8 | Participants | ||
| Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9). | Placebo | 4 | Participants | ||
| Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9). | Fostamatinib 150 mg | 8 | Participants |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fostamatinib 150 mg | 25 | |
| Overall Study | STARTED | Fostamatinib 100 mg | 26 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | COMPLETED | Fostamatinib 150 mg | 20 | |
| Overall Study | COMPLETED | Fostamatinib 100 mg | 24 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Fostamatinib 150 mg | 5 | |
| Overall Study | NOT COMPLETED | Fostamatinib 100 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Fostamatinib 150 mg | 7 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | Fostamatinib 100 mg | 9 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 7 | 25 | |
| other | Nausea | Gastrointestinal disorders | Fostamatinib 150 mg | 5 | 25 | |
| other | Nausea | Gastrointestinal disorders | Fostamatinib 100 mg | 6 | 26 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Fostamatinib 150 mg | 4 | 25 | |
| other | Vomiting | Gastrointestinal disorders | Fostamatinib 100 mg | 3 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 25 | |
| other | Abdominal Pain | Gastrointestinal disorders | Fostamatinib 150 mg | 0 | 25 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fostamatinib 150 mg | 1 | 25 |
| Total, all-cause mortality | Fostamatinib 100 mg | 0 | 26 |
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, other adverse events | Fostamatinib 150 mg | 24 | 25 |
| Total, other adverse events | Fostamatinib 100 mg | 22 | 26 |
| Total, other adverse events | Placebo | 21 | 25 |
| Total, serious adverse events | Fostamatinib 150 mg | 2 | 25 |
| Total, serious adverse events | Fostamatinib 100 mg | 2 | 26 |
| Total, serious adverse events | Placebo | 2 | 25 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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