| Trial ID: | L0696 |
| Source ID: | NCT04696146
|
| Associated Drug: |
Berinert
|
| Title: |
Berinert (C1INH) vs Placebo for DGF/IRI
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04696146/results
|
| Conditions: |
End Stage Renal Disease|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Berinert|DRUG: Placebo
|
| Outcome Measures: |
Primary: Need for Dialysis in the First 30 Days Post-transplant, The percentage of patients enrolled who require at least one session of dialysis in the first 30 days post transplant., 30 days|Renal Function 6 Months, eGFR at 6M post-transplant, 6 months|Graft Survival 6 Months, Number of participants with graft survival at 6 Months, 6 months | Secondary: Rejection Episodes at 6 Months, Number of participants with a rejection episodes by day 180, Month 6|Development of Donor Specific Antibodies (DSA) at 6 Months, Number of participants with Donor Specific Antibodies (DSA) at 6 Months, Month 6 | Other: Adverse Events in the Study Population, Number of participants with an adverse events and serious adverse events, Month 6
|
| Sponsor/Collaborators: |
Sponsor: Cedars-Sinai Medical Center | Collaborators: OneLegacy Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2021-03-03
|
| Completion Date: |
2024-10-31
|
| Results First Posted: |
2023-09-29
|
| Last Update Posted: |
2024-12-04
|
| Locations: |
Cedars Sinai Medical Center, Los Angeles, California, 90048, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04696146
|
