NCT02907554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
648

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

December 19, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2023

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

September 5, 2016

Last Update Submit

December 13, 2024

Conditions

Brain DeathKidney Transplantation

Keywords

PreconditioningTissue and organ procurementCyclosporine AKidney transplantationDelayed graft function

Outcome Measures

Primary Outcomes (1)

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

    within the 7 days following renal transplantation.

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

control group

PLACEBO COMPARATOR

control group receives a placebo

Drug: Placebo

intervention group

EXPERIMENTAL

the intervention group receives 2.5 mg/kg of cyclosporine

Drug: cyclosporine A

Interventions

cyclosporine ADRUG

the intervention group receives 2.5 mg/kg of cyclosporine

intervention group
PlaceboDRUG

control group receives a placebo

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For organ donors:
  • Male and females aged 18 to 80 years
  • Brain death
  • Male and females aged 18 to 80 years
  • Indication of kidney transplantation
  • Informed consent

You may not qualify if:

  • 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).
  • Need for a double kidney transplantation.
  • Need for a multiorgan transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 29665840DERIVED

MeSH Terms

Conditions

Brain DeathDelayed Graft Function

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Carole ICHAI

    CHU NICE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 20, 2016

Study Start

December 19, 2017

Primary Completion

April 10, 2022

Study Completion

April 3, 2023

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)