Comparison · NCT02134314-3aa02931
C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)
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. C1-Inhibitor (Berinert) (Human) (C1INH) vs Normal Saline: Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale). Trial comparisons, record NCT02134314-3aa02931. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02134314-3aa02931
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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 | 0.441 | 0.289 | 0.605 | wilson | |
| Risk in group 2 | 0.6 | 0.436 | 0.744 | wilson | |
| Risk difference, group 1 minus group 2 | -0.159 | -0.369 | 0.0735 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.735 | 0.462 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.526 | 0.202 | 1.37 | log | |
| Number needed to treat, for one fewer participant with the outcome on C1-Inhibitor (Berinert) (Human) (C1INH) than on Normal Saline | 6.3 | 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 | C1-Inhibitor (Berinert) (Human) (C1INH) | 35 patients will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 50 units/kg IVPB administered on day of transplant, and another dose 24 hours post op. Total: 2 doses | 15 | 34 | OG000 |
| Group 2 | Normal Saline | 35 patients will receive placebo in addition to standard of care immunosuppressive therapy.~Placebo: Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose 24 hours post op. Total: 2 doses | 21 | 35 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)
- Description
DGF Scale:~Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \>70%~Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \>70% with need for dialysis~Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation \<70% with no need for dialysis~Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of \<70% with need for dialysis.
- Time frame
- First 7 days post-transplant
- Population
Source ClinicalTrials.gov
Trial
- Title
- C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
- NCT number
- NCT02134314
- Phases
- PHASE1, PHASE2
- Conditions
- End Stage Renal Disease, Kidney Failure, Delayed Graft Function, Ischemic Reperfusion Injury
- Interventions
- C1 Esterase Inhibitor, Placebo
- Lead sponsor
- Cedars-Sinai Medical Center
- Results first posted
- 2018-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02134314?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.govNone 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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