Comparison · NCT01180036-sae
Rituximab Treatment Arm vs Cyclosporine Treatment Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rituximab Treatment Arm vs Cyclosporine Treatment Arm: serious adverse events. Trial comparisons, record NCT01180036-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01180036-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.169 | 0.0972 | 0.278 | wilson | |
| Risk in group 2 | 0.308 | 0.209 | 0.428 | wilson | |
| Risk difference, group 1 minus group 2 | -0.138 | -0.279 | 0.00862 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.55 | 0.287 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.458 | 0.199 | 1.06 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rituximab Treatment Arm than on Cyclosporine Treatment Arm | 7.22 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rituximab Treatment Arm | Patients randomized to the RTX arm will receive 1000 mg IV on Days 1 and 15. Patients who achieve complete remission at 6 months will not be retreated. A second course of RTX 1000 mg IV will be administered at study month 6 for individuals who have not achieved a complete remission, but have achieved a minimum of \>25% reduction in Time 0 proteinuria. Dosing at study month 6 will be independent of CD19+ B cell count.~Rituximab: 1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of CD19+ B cell count | 11 | 65 | EG000 |
| Group 2 | Cyclosporine Treatment Arm | Patients randomized to the Cyclosporine arm will be started at a dose of CsA = 3.5 mg/kg/day p.o. divided into 2 equal doses given at 12 hour intervals. Target trough CsA blood levels are 125 to 175 ng/ml. Patients will have their doses adjusted according to their blood levels of CSA as monitored every 2 weeks until the target trough level is reached. If a complete remission is achieved by 6 months, CSA will be tapered and discontinued over a three-month period. If after 6 months there has not been a reduction in proteinuria of at least 25% of baseline values, the drug will also be discontinued. If there has been a \>25% reduction in baseline proteinuria (but not complete remission) the CSA will be continued for an additional 6 months. | 20 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events will be collected from enrollment through month 18, for each subject, approximately 18 months total.
Source ClinicalTrials.gov
Trial
- Title
- MEmbranous Nephropathy Trial Of Rituximab
- NCT number
- NCT01180036
- Phases
- PHASE2, PHASE3
- Conditions
- Idiopathic Membranous Nephropathy
- Interventions
- Rituximab, Cyclosporine
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2019-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01180036?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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