Limoges, 87 042, France
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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
-
Number of Death
Time frame: 4 years
Secondary outcomes
-
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.
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