Cyclosporine a Pretreatment and Kidney Graft Function

Phase 4

Completed

• Conditions: Brain Death; Kidney Transplantation
• Interventions: Drug: cyclosporine A; Drug: Placebo

• Registration Number: NCT02907554
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2017-12-19
• Primary Completion: 2022-04-10
• Study Completion: 2023-04-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 648

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	cyclosporine A	the intervention group receives 2.5 mg/kg of cyclosporine
control group	Placebo	control group receives a placebo

Primary Outcome Measures

Name	Time	Method
Percentage of delayed graft function defined by a need of at least one hemodialysis session	within the 7 days following renal transplantation.

Secondary Outcome Measures

Name	Time	Method
Percentage of acute and chronic graft rejection	during the first year after transplantation
Mortality	during the first year after transplantation
Postoperative evolution of estimated creatinine clearance	at day 3 and 7
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
Percentage of primary graft dysfunction	during the first year after transplantation
hospital length of stay	at day 1	after transplantation

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France