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Cys-A-Rein: Cyclosporine A Pretreatment and Kidney Graft Function

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Recruiting
CT.gov ID
NCT02907554
Collaborator
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) (Other), Poitiers University Hospital (Other), University Hospital, Toulouse (Other), Hôpital de la Timone (Other)
648
Enrollment
1
Location
2
Arms
57
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: cyclosporine A
  • Drug: Placebo
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
648 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial
Actual Study Start Date :
Dec 19, 2017
Anticipated Primary Completion Date :
Jun 19, 2022
Anticipated Study Completion Date :
Sep 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Percentage of slow graft function defined by a urine output < 1000 ml [at on 1 day after transplantation]

  2. 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]

  3. Postoperative evolution of estimated creatinine clearance [at day 3 and 7]

  4. Percentage of acute and chronic graft rejection [during the first year after transplantation]

  5. Percentage of primary graft dysfunction [during the first year after transplantation]

  6. hospital length of stay [at day 1]

    after transplantation

  7. Mortality [during the first year after transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Clermont-Ferrand Clermont-Ferrand France 63003

Sponsors and Collaborators

  • University Hospital, Clermont-Ferrand
  • 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

Investigators

  • Principal Investigator: Carole ICHAI, CHU Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT02907554
Other Study ID Numbers:
  • CHU-0276
  • 2014-003544-12
First Posted:
Sep 20, 2016
Last Update Posted:
Jul 7, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Clermont-Ferrand
Preconditioning
Tissue and organ procurement
Cyclosporine A
Kidney transplantation
Delayed graft function
Additional relevant MeSH terms:
Brain Death
Cyclosporine
Cyclosporins

Study Results

No Results Posted as of Jul 7, 2020