Cyclosporine A Pretreatment and Kidney Graft Function (Cys-A-Rein)

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation; Brain Death
• Intervention / Treatment: Drug: Placebo; Drug: cyclosporine A

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 Type: Interventional
• Enrollment (Anticipated): 648
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patrick LACARIN; Phone Number: 04 73 75 11 95; Email: placarin@chu-clermontefrrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; control group receives a placebo	Drug: Placebo; control group receives a placebo
Experimental: intervention group; the intervention group receives 2.5 mg/kg of cyclosporine	Drug: cyclosporine A; the intervention group receives 2.5 mg/kg of cyclosporine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Montpellier; Poitiers University Hospital; Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Nīmes; University Hospital, Toulouse; Groupe Hospitalier Pitie-Salpetriere; University Hospital, Estaing; Hôpital de la Timone; Hôtel Dieu (Nantes)
• Investigators: Principal Investigator: Carole Ichai, CHU Nice

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Anticipated): June 19, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Kidney transplantation; Cyclosporine A; Preconditioning; Delayed graft function; Tissue and organ procurement
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Death; Unconsciousness; Consciousness Disorders; Coma; Brain Death; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: CHU-0276; 2014-003544-12 (Other Identifier: 2014-003544-12)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No