Brain Death, Kidney Transplantation
Conditions
Keywords
Preconditioning, Tissue and organ procurement, Cyclosporine A, Kidney transplantation, Delayed graft function
Brief summary
Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.
Detailed description
Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.
Interventions
DRUGcyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine
DRUGPlacebo
control group receives a placebo
Sponsors
University Hospital, Clermont-Ferrand
University Hospital, Estaing
Centre Hospitalier Universitaire de Nice
Groupe Hospitalier Pitie-Salpetriere
Centre Hospitalier Universitaire de Nīmes
University Hospital, Montpellier
Hôtel Dieu (Nantes)
Poitiers University Hospital
University Hospital, Toulouse
Hôpital de la Timone
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
For organ donors: * Male and females aged 18 to 80 years * Brain death Inclusion criteria for organ recipients: * Male and females aged 18 to 80 years * Indication of kidney transplantation * Informed consent
Exclusion criteria
For organ donors: * Contra-indication for multiorgan procurement (infections, cancer, etc) * Preexistent chronic renal failure. * Refusal for organ procurement by the donor (confirmed by the French national register or reported by the next-of-kin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of delayed graft function defined by a need of at least one hemodialysis session | within the 7 days following renal transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of slow graft function defined by a urine output < 1000 ml | at on 1 day after transplantation | — |
| Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70% | at day 3 and 7 after transplantation | — |
| Postoperative evolution of estimated creatinine clearance | at day 3 and 7 | — |
| Percentage of acute and chronic graft rejection | during the first year after transplantation | — |
| Percentage of primary graft dysfunction | during the first year after transplantation | — |
| hospital length of stay | at day 1 | after transplantation |
| Mortality | during the first year after transplantation | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCarole ICHAI
Centre Hospitalier Universitaire de Nice
Outcome results
None listed