Cyclosporine a Pretreatment and Kidney Graft Function

University Hospital, Clermont-Ferrand648 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

648

Conditions

Brain Death Kidney Transplantation

Interventions

cyclosporine ADRUG

the intervention group receives 2.5 mg/kg of cyclosporine

PlaceboDRUG

control group receives a placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Percentage of delayed graft function defined by a need of at least one hemodialysis session

Time frame: within the 7 days following renal transplantation.

Secondary Outcomes

Percentage of slow graft function defined by a urine output < 1000 ml

Time frame: 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%

Time frame: at day 3 and 7 after transplantation

Postoperative evolution of estimated creatinine clearance

Time frame: at day 3 and 7

Percentage of acute and chronic graft rejection

Time frame: during the first year after transplantation

Percentage of primary graft dysfunction

Time frame: during the first year after transplantation

hospital length of stay

after transplantation

Time frame: at day 1

Mortality

Time frame: during the first year after transplantation

Data from ClinicalTrials.gov

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