Renal TransplantEPHEGRENNCT01989832
Pharmaco-economical Study in Kidney Transplantation
An observational study of Renal Transplant, run by University Hospital, Limoges at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- How many people
- 570 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: renal transplant patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Transplant
- Keywords
- cohort, pharmaco-economic, kidney, transplantation, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biological and clinical Data collected | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Death
Measured: 4 years
Secondary outcomes (1)
to examine nature, dose and exposure in immunosuppresseurs.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989832
- Sponsor's protocol ID
- I10007
- Acronym
- EPHEGREN
- Status last verified
- Jun 2014
- First submitted
- 4 Nov 2013
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaco-economical Study in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01989832
- Acronym / sponsor ID
- EPHEGREN / I10007
- Conditions
- Renal Transplant
- Keywords
- cohort, pharmaco-economic, kidney, transplantation, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological and clinical Data collected | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- renal transplant patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Death
Time frame: 4 years
1 secondary outcome
to examine nature, dose and exposure in immunosuppresseurs.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Death (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.