| Trial ID: | L1521 |
| Source ID: | NCT04180085
|
| Associated Drug: |
Belatacept Injection
|
| Title: |
Pilot Study: Interest of Belatacept As a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients At Risk of Chronic Renal Failure (BELACOEUR)
|
| Acronym: |
BELACOEUR
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Heart Transplant Failure
|
| Interventions: |
DRUG: Belatacept Injection
|
| Outcome Measures: |
Primary: Clearance, Determination of plasma creatinine and calculation of clearance according to the formula CKD EPI (Chronic Kidney Disease - Epidemiology Collaboration) at 3 months and 12 months post heart transplantation, 12 months | Secondary: Myocardial biopsies, Myocardial biopsies between 3 months and 12 months post Cardiac Transplantation to check the risk of rejection, 12 months|Anti-human leukocyte antigen antibody assay, To check the risk of rejection, 12 months|Fasting blood glucose and glycated haemoglobin (HBA1C), Measurement of the New Onset Diabetes After Transplantation, 12 months|Death, Evaluate the mortality specific to 12 months post cardiac transplantation (Estimate: percentage of patients who died at 12 months)., 12 months|Number of dialysis sessions, Evaluate the use of renal replacement therapy between 3 months and 12 months after Cardiac Transplantation., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Nantes University Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-02-06
|
| Completion Date: |
2026-01-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-29
|
| Locations: |
Karine Nubret, Bordeaux, France|Laurent Sebbag, Lyon, France|Claire Garandeau, Nantes, France|Bertrand Lelong, Rennes, France
|
| URL: |
https://clinicaltrials.gov/show/NCT04180085
|
