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Cyclosporine a Pretreatment and Kidney Graft Function

NCT02907554 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

  • Brain Death
  • Kidney Transplantation

Interventions

DRUG

cyclosporine A

the intervention group receives 2.5 mg/kg of cyclosporine

DRUG

Placebo

control group receives a placebo

Sponsors & Collaborators

  • University Hospital, Estaing

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nice

    collaborator OTHER

  • Groupe Hospitalier Pitie-Salpetriere

    collaborator OTHER

  • Centre Hospitalier Universitaire de Nīmes

    collaborator OTHER

  • University Hospital, Montpellier

    collaborator OTHER

  • Hôtel Dieu (Nantes)

    collaborator UNKNOWN

  • Poitiers University Hospital

    collaborator OTHER

  • University Hospital, Toulouse

    collaborator OTHER

  • Hôpital de la Timone

    collaborator OTHER

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Carole ICHAI · CHU NICE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2022-04-10
Completion
2023-04-03

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907554 on ClinicalTrials.gov