Cyclosporine A Pretreatment and Kidney Graft Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial

Conditions
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Brain Death, Kidney Transplantation

Intervention / Treatment
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* Drug: cyclosporine A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For organ donors: Male and females aged 18 to 70 years Brain death Inclusion criteria for organ recipients: Male and females aged 18 to 70 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>control group receives a placebo | Drug: Placebo<br>* control group receives a placebo<br>|
| Experimental: intervention group<br>the intervention group receives 2.5 mg/kg of cyclosporine | Drug: cyclosporine A<br>* the intervention group receives 2.5 mg/kg of cyclosporine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | after transplantation | at day 1 | 
| Mortality |  | during the first year after transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preconditioning, Tissue and organ procurement, Cyclosporine A, Kidney transplantation, Delayed graft function