Comparison · NCT00307125-4630bcb3
Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy
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. Pilot Phase-Rituximab Plus Immunosuppression vs Pilot Phase-Placebo Plus Immunosuppression: Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy. Trial comparisons, record NCT00307125-4630bcb3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00307125-4630bcb3
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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 | 0 | 0.204 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.354 | 0.204 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Pilot Phase-Rituximab Plus Immunosuppression | Adult Dosing (Subjects \> 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific. | 0 | 15 | OG000 |
| Group 2 | Pilot Phase-Placebo Plus Immunosuppression | Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific. | 0 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Experiencing Loss of Peritubular Capillary (PTC) C4d Staining on Kidney Biopsy
- Description
- Number of participants with loss of PTC C4d staining on kidney (renal) biopsy within 12 months post treatment initiation. PTC C4d staining on biopsy indicates organ rejection.
- Time frame
- 1 year post treatment initiation
- Population
- Intent-to-treat
Source ClinicalTrials.gov
Trial
- Title
- Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies
- NCT number
- NCT00307125
- Phases
- PHASE2
- Conditions
- Kidney Transplant, Kidney Transplant Recipient, Graft Function/Survival, de Novo HLA Antibodies Development
- Interventions
- Rituximab plus immunosuppression, Placebo plus immunosuppression
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2015-03-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00307125?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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