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Trial · NCT02134314

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.First 7 days post-transplantNumber of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5
PrimaryNumber of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.First 7 days post-transplantThe proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).
PrimaryNumber of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.First 7 days post-transplantNumber of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant.
PrimaryNumber of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.First 7 days post-transplantMean quantity of dialysis sessions per patient in the first 7 days post transplant.
SecondarySerum CreatinineUp to 90 days post-transplantMean serum creatinine on day 90 in mg/dL
SecondaryCreatinine ClearanceUp to 90 days post-transplantCreatinine clearance calculated based on serum creatinine, milliliters per minute.
Secondary24h Urine Output24 hours post-transplant24 hour urine output post-transplantation measured in milliliters
SecondaryMean Number of Patients on Dialysis15 to 30 days post-transplantationMean number of patients on dialysis at 15 to 30 days post-transplant
SecondaryNumber of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)First 7 days post-transplant
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.
OtherOverall Incidence of Serious Adverse EventsUp to 9 months post-transplantOverall incidence of serious adverse events in the C1INH and placebo groups, number of events.
OtherPatient SurvivalUp to 90 days post-transplantPatient survival at 90 days post-transplantation
OtherRate of Acute Cellular Rejection (ACR)Up to 90 days post-transplantNumber of acute cellular and antibody mediated rejection episodes by day 90.
OtherGraft SurvivalDay 90 Post-transplantNumber of Participants with Graft Survival at 90 Days Post-Transplant

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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