Clinical trial NCT02907554: Cyclosporine a Pretreatment and Kidney Graft Function
Official title: Effects of Cyclosporine a Pretreatment of Deceased Donor on Kidney Graft Function: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Death
Kidney Transplantation
Keywords: Preconditioning
Tissue and organ procurement
Cyclosporine A
Kidney transplantation
Delayed graft function
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
name: Centre Hospitalier Universitaire de Nice
name: Groupe Hospitalier Pitie-Salpetriere
name: Centre Hospitalier Universitaire de Nīmes
name: University Hospital, Montpellier
name: Hôtel Dieu (Nantes)
name: Poitiers University Hospital
name: University Hospital, Toulouse
name: Hôpital de la Timone
First posted: 2016-09-20
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Exclusion criteria for organ recipients:

* Need for a double kidney transplantation.
* Need for a multiorgan transplantation

Primary outcomes:
measure: Percentage of delayed graft function defined by a need of at least one hemodialysis session
timeFrame: within the 7 days following renal transplantation.
Secondary outcomes:
measure: Percentage of slow graft function defined by a urine output < 1000 ml
timeFrame: at on 1 day after transplantation
measure: Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70%
timeFrame: at day 3 and 7 after transplantation
measure: Postoperative evolution of estimated creatinine clearance
timeFrame: at day 3 and 7
measure: Percentage of acute and chronic graft rejection
timeFrame: during the first year after transplantation
measure: Percentage of primary graft dysfunction
timeFrame: during the first year after transplantation
measure: hospital length of stay
timeFrame: at day 1
measure: Mortality
timeFrame: during the first year after transplantation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: CHU NICE
name: Carole ICHAI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRea network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4.