Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
648 participants
INTERVENTIONAL
2017-12-19
2023-04-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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control group
control group receives a placebo
Placebo
control group receives a placebo
intervention group
the intervention group receives 2.5 mg/kg of cyclosporine
cyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine
Interventions
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cyclosporine A
the intervention group receives 2.5 mg/kg of cyclosporine
Placebo
control group receives a placebo
Eligibility Criteria
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Inclusion Criteria
* Male and females aged 18 to 80 years
* Brain death
* Male and females aged 18 to 80 years
* Indication of kidney transplantation
* Informed consent
Exclusion Criteria
* 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).
* Need for a double kidney transplantation.
* Need for a multiorgan transplantation
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Estaing
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
University Hospital, Montpellier
OTHER
Hôtel Dieu (Nantes)
UNKNOWN
Poitiers University Hospital
OTHER
University Hospital, Toulouse
OTHER
Hôpital de la Timone
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Carole ICHAI
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
Locations
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CHU Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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References
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Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRea network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4.
Other Identifiers
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2014-003544-12
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP_2014_CONSTANTIN
Identifier Type: -
Identifier Source: org_study_id