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OpenTrials
Completed

NCT Number: NCT01989832

Pharmaco-economical Study in Kidney Transplantation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges, 87 042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Death

    Time frame: 4 years

Secondary outcomes

  1. to examine nature, dose and exposure in immunosuppresseurs.

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: EPHEGREN

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2013
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.