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

Primary Purpose

Brain Death, Kidney Transplantation

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
cyclosporine A
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Death focused on measuring Preconditioning, Tissue and organ procurement, Cyclosporine A, Kidney transplantation, Delayed graft function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

intervention group

Arm Description

control group receives a placebo

the intervention group receives 2.5 mg/kg of cyclosporine

Outcomes

Primary Outcome Measures

Percentage of delayed graft function defined by a need of at least one hemodialysis session

Secondary Outcome Measures

Percentage of slow graft function defined by a urine output < 1000 ml
Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70%
Postoperative evolution of estimated creatinine clearance
Percentage of acute and chronic graft rejection
Percentage of primary graft dysfunction
hospital length of stay
after transplantation
Mortality

Full Information

First Posted
September 5, 2016
Last Updated
July 2, 2020
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Hospital, Estaing, Centre Hospitalier Universitaire de Nice, Groupe Hospitalier Pitie-Salpetriere, Centre Hospitalier Universitaire de Nīmes, University Hospital, Montpellier, Hôtel Dieu (Nantes), Poitiers University Hospital, University Hospital, Toulouse, Hôpital de la Timone
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1. Study Identification

Unique Protocol Identification Number
NCT02907554
Brief Title
Cyclosporine A Pretreatment and Kidney Graft Function
Acronym
Cys-A-Rein
Official Title
Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
June 19, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Hospital, Estaing, Centre Hospitalier Universitaire de Nice, Groupe Hospitalier Pitie-Salpetriere, Centre Hospitalier Universitaire de Nīmes, University Hospital, Montpellier, Hôtel Dieu (Nantes), Poitiers University Hospital, University Hospital, Toulouse, Hôpital de la Timone

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death, Kidney Transplantation
Keywords
Preconditioning, Tissue and organ procurement, Cyclosporine A, Kidney transplantation, Delayed graft function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
648 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
control group receives a placebo
Arm Title
intervention group
Arm Type
Experimental
Arm Description
the intervention group receives 2.5 mg/kg of cyclosporine
Intervention Type
Drug
Intervention Name(s)
cyclosporine A
Intervention Description
the intervention group receives 2.5 mg/kg of cyclosporine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
control group receives a placebo
Primary Outcome Measure Information:
Title
Percentage of delayed graft function defined by a need of at least one hemodialysis session
Time Frame
within the 7 days following renal transplantation.
Secondary Outcome Measure Information:
Title
Percentage of slow graft function defined by a urine output < 1000 ml
Time Frame
at on 1 day after transplantation
Title
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
Title
Postoperative evolution of estimated creatinine clearance
Time Frame
at day 3 and 7
Title
Percentage of acute and chronic graft rejection
Time Frame
during the first year after transplantation
Title
Percentage of primary graft dysfunction
Time Frame
during the first year after transplantation
Title
hospital length of stay
Description
after transplantation
Time Frame
at day 1
Title
Mortality
Time Frame
during the first year after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontefrrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole ICHAI
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
29665840
Citation
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.
Results Reference
derived

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Cyclosporine A Pretreatment and Kidney Graft Function

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