Pharmaco-economical Study in Kidney Transplantation

Renal Transplant Clinical Trial

— EPHEGREN  

Official title:

Pharmaco-economical Study in Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989832
• Other study ID #: I10007
• Status: Completed
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: June 2014
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Death		4 years
Secondary	to examine nature, dose and exposure in immunosuppresseurs.		4 years