A Phase 4 interventional study of cyclosporine A and Placebo in Brain Death and Kidney Transplantation, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 648 is above the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For organ donors:
Inclusion criteria for organ recipients:
Exclusion Criteria:
For organ donors:
Exclusion criteria for organ recipients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
control group receives a placebo
Drug: Placebo
the intervention group receives 2.5 mg/kg of cyclosporine
Drug: cyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine
control group receives a placebo
Percentage of delayed graft function defined by a need of at least one hemodialysis session
Time frame: within the 7 days following renal transplantation.
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
Ran from Dec 2017 to primary completion in Apr 2022, 51 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cyclosporine
University Hospital, Clermont-Ferrand →