Cyclosporine A Pretreatment and Kidney Graft Function

Kidney Transplantation Clinical Trial

— Cys-A-Rein  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02907554
• Other study ID #: CHU-0276
• Secondary ID: 2014-003544-12
• Status: Recruiting
• Phase: Phase 4
• Start date: December 19, 2017
• Est. completion date: September 20, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontefrrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 648
• Est. completion date: September 20, 2022
• Est. primary completion date: June 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Kidney Transplantation

Intervention

Drug:
• cyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine
• Placebo
control group receives a placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (10)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire de Nimes, Groupe Hospitalier Pitie-Salpetriere, Hôpital de la Timone, Hôtel Dieu (Nantes), Poitiers University Hospital, University Hospital, Estaing, University Hospital, Montpellier, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of delayed graft function defined by a need of at least one hemodialysis session		within the 7 days following renal transplantation.
Secondary	Percentage of slow graft function defined by a urine output < 1000 ml		at on 1 day after transplantation
Secondary	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
Secondary	Postoperative evolution of estimated creatinine clearance		at day 3 and 7
Secondary	Percentage of acute and chronic graft rejection		during the first year after transplantation
Secondary	Percentage of primary graft dysfunction		during the first year after transplantation
Secondary	hospital length of stay	after transplantation	at day 1
Secondary	Mortality		during the first year after transplantation