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EPHEGREN: Pharmaco-economical Study in Kidney Transplantation

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT01989832
Collaborator
(none)
570
Enrollment
1
Location
58
Actual Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases …).

According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.

EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    570 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmaco-economical Study in Kidney Transplantation
    Actual Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2017
    Actual Study Completion Date :
    Dec 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Biological and clinical Data collected

    Outcome Measures

    Primary Outcome Measures

    1. Number of Death [4 years]

    Secondary Outcome Measures

    1. to examine nature, dose and exposure in immunosuppresseurs. [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients in the first month of renal graft, or patients already included in an other epidemiological French study (EPIGREN) in the 0-6 month period

    • Men of women aged more than 18 years

    • Patients able to exercise in writing their informed and free consent to participate to the biological collection

    • Patients not opposing to collect their medical data

    • Patients registered with a social security system

    • Patients able to complete the questionnaires

    Exclusion Criteria:

    • Patients aged less than 18 years and patients under guardianship

    • Patients with a follow-up at another center other than those part of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Limoges France 87 042

    Sponsors and Collaborators

    • University Hospital, Limoges

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT01989832
    Other Study ID Numbers:
    • I10007
    First Posted:
    Nov 21, 2013
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Jun 1, 2014
    Keywords provided by University Hospital, Limoges
    cohort
    pharmaco-economic
    kidney
    transplantation
    quality of life

    Study Results

    No Results Posted as of Jan 11, 2019