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Clinical Trial Details

Trial ID: L1554
Source ID: NCT02134314
Associated Drug: C1 Esterase Inhibitor
Title: C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
Acronym: C1INHDGF
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02134314/results
Conditions: End Stage Renal Disease|Kidney Failure|Delayed Graft Function|Ischemic Reperfusion Injury
Interventions: DRUG: C1 Esterase Inhibitor|DRUG: Placebo
Outcome Measures: Primary: Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5., Number of participants in the C1INH and placebo groups with serum creatinine \>3mg/dL on postoperative day 5, First 7 days post-transplant|Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant., The 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)., First 7 days post-transplant|Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant., Number of patients in the C1INH and placebo groups with serum creatinine reduction of \< 30% from 24 to 48 hours post-transplant., First 7 days post-transplant|Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant., Mean quantity of dialysis sessions per patient in the first 7 days post transplant., First 7 days post-transplant | Secondary: Serum Creatinine, Mean serum creatinine on day 90 in mg/dL, Up to 90 days post-transplant|Creatinine Clearance, Creatinine clearance calculated based on serum creatinine, milliliters per minute., Up to 90 days post-transplant|24h Urine Output, 24 hour urine output post-transplantation measured in milliliters, 24 hours post-transplant|Mean Number of Patients on Dialysis, Mean number of patients on dialysis at 15 to 30 days post-transplant, 15 to 30 days post-transplantation|Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale), 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., First 7 days post-transplant | Other: Overall Incidence of Serious Adverse Events, Overall incidence of serious adverse events in the C1INH and placebo groups, number of events., Up to 9 months post-transplant|Patient Survival, Patient survival at 90 days post-transplantation, Up to 90 days post-transplant|Rate of Acute Cellular Rejection (ACR), Number of acute cellular and antibody mediated rejection episodes by day 90., Up to 90 days post-transplant|Graft Survival, Number of Participants with Graft Survival at 90 Days Post-Transplant, Day 90 Post-transplant
Sponsor/Collaborators: Sponsor: Cedars-Sinai Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2014-09
Completion Date: 2017-03-13
Results First Posted: 2018-06-25
Last Update Posted: 2018-06-25
Locations: Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
URL: https://clinicaltrials.gov/show/NCT02134314