NCT01989832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 11, 2019

Status Verified

June 1, 2014

Enrollment Period

4.4 years

First QC Date

November 4, 2013

Last Update Submit

January 10, 2019

Conditions

Renal Transplant

Keywords

cohortpharmaco-economickidneytransplantationquality of life

Outcome Measures

Primary Outcomes (1)

  • Number of Death

    4 years

Secondary Outcomes (1)

  • to examine nature, dose and exposure in immunosuppresseurs.

    4 years

Study Arms (1)

Biological and clinical Data collected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

renal transplant patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Limoges, 87 042, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 21, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

January 11, 2019

Record last verified: 2014-06

Locations

FR(1)