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Comparison · NCT01120028-e7809c46

Period 1: Alemtuzumab/Tacrolimus vs Period 1: Basiliximab/Tacrolimus: Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Period 1: Alemtuzumab/Tacrolimus vs Period 1: Basiliximab/Tacrolimus: Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy. Trial comparisons, record NCT01120028-e7809c46. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01120028-e7809c46

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.07280.05170.101wilson
Risk in group 20.160.1280.197wilson
Risk difference, group 1 minus group 2-0.0869-0.13-0.0441newcombe hybrid score
Risk ratio, group 1 over group 20.4560.3050.682log
Odds ratio, group 1 over group 20.4130.2640.647log
Number needed to treat, for one fewer participant with the outcome on Period 1: Alemtuzumab/Tacrolimus than on Period 1: Basiliximab/Tacrolimus11.57.6922.7from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Period 1: Alemtuzumab/Tacrolimus
Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus~Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart~Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab.
31426OG000
Group 2Period 1: Basiliximab/TacrolimusInduction therapy allocation: Basiliximab and Tacrolimus~Basiliximab: 20 mg intravenously, two doses 96 hours apart~Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab68426OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy
Description
Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus))
Time frame
6 months post-transplantation
Population

Source ClinicalTrials.gov

Trial

Title
Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy
NCT number
NCT01120028
Phases
PHASE2, PHASE3
Conditions
Kidney Transplantation
Interventions
Alemtuzumab, Basiliximab, Sirolimus, Tacrolimus
Lead sponsor
University of Oxford
Results first posted
2019-10-01

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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