Cardiac TransplantationPhase 4COREVNCT00716573
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure
A Phase 4 study testing everolimus in people with Cardiac Transplantation and Chronic Renal Insufficiency, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Transplantation, Chronic Renal Insufficiency
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2008to 17 Apr 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female cardiac recipients over 18 years old
- First or second heart transplant, more than one year following surgery
- Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
Who cannot join
- Current CNI-free immunosuppressive regimen
- Patients currently or previously treated with a mTOR inhibitor any time prior randomization
- Patients who are recipients for a multiple solid organ transplant
- Treated acute rejection episode within three months prior randomization
- Congestive heart failure (NYHA class III or IV) and/or VEF < 30 % and/or patient waiting for a re-transplantation
- Scheduled surgical intervention
Show all 21Show fewer
- Platelet count < 50 G/l
- Severe hepatic insufficiency (SGPT and/or SGOT > 3N)
- Major lipidic profile abnormalities (total cholesterol > 3g/l and/or TG > 5g/l)
- Proteinuria/creatinuria > 0,08 g/mmol
- Severe renal failure attested by cGFR < 30 ml/min/1.73m² (MDRD4)
- History of Hypersensitivity to everolimus, sirolimus or excipients
- History of Hypersensitivity to macrolides
- Pregnancy and breast feeding
- Childbearing age women without efficient contraception
- Law protected patients
- Patients in emergency unable to express their consent
- History of Hypersensitivity to cyclosporine or St-John's wort, stiripentol, bosentan, rosuvastatin
- History of Hypersensitivity to tacrolimus, macrolides or excipients
- History of Hypersensitivity to azathioprine
- History of Hypersensitivity to mycophénolate mofetil or excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COREV : A Multi-center, Randomized, Open-label Study Evaluating the Efficacy on Renal Function of Everolimus in Heart Transplant Recipients With Established Chronic Renal Failure
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.
This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :
- Renal function improvement
- Vasculopathy and major cardiac event reduction
- Maintenance of immunosuppressive efficacy
- Being tested
- everolimus
- Keywords
- Cardiac transplantation, Chronic renal insufficiency, Everolimus
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called Certican
0,75 mg bid, 24 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Introduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule Receives: Drug: everolimus |
| 2 | No intervention | Maintain of their current immunosuppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
Measured: 12 months
Secondary outcomes (6)
Evaluation of the benefit of everolimus introduction on renal function at 24 months
Measured: 24 months
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)
Measured: 24 months
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)
Measured: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals
Measured: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection
Measured: 24 months
Evaluation of the benefit of everolimus introduction on safety
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study start16 Sep 2008
- Primary completion17 Apr 2014
- Study completion17 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale BOISSONNAT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716573
- Sponsor's protocol ID
- 2007.495
- Acronym
- COREV
- Status last verified
- Jun 2017
- First submitted
- 15 Jul 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COREV : A Multi-center, Randomized, Open-label Study Evaluating the Efficacy on Renal Function of Everolimus in Heart Transplant Recipients With Established Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00716573
- Acronym / sponsor ID
- COREV / 2007.495
- Keywords
- Cardiac transplantation, Chronic renal insufficiency, Everolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Sep 2008 (actual)
- Primary completion
- 17 Apr 2014 (actual)
- Study completion
- 17 Apr 2014 (actual)
- First posted
- 16 Jul 2008 (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.
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.
This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :
- Renal function improvement
- Vasculopathy and major cardiac event reduction
- Maintenance of immunosuppressive efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: everolimusIntroduction of everolimus associated with CNI (ciclosporin or tacrolimus) reduction (50%) to the current immunosuppression schedule |
| 2 | No intervention | –Maintain of their current immunosuppressive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female cardiac recipients over 18 years old
- First or second heart transplant, more than one year following surgery
- Patients with renal failure assessed by cGFR 30 to 60 ml/min/1,73m² calculated by MDRD4 formula
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
Key exclusion criteria (21 listed)
- Current CNI-free immunosuppressive regimen
- Patients currently or previously treated with a mTOR inhibitor any time prior randomization
- Patients who are recipients for a multiple solid organ transplant
- Treated acute rejection episode within three months prior randomization
- Congestive heart failure (NYHA class III or IV) and/or VEF < 30 % and/or patient waiting for a re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimusAlso: Certican0,75 mg bid, 24 months | Drug | 1 |
Primary outcome
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
Time frame: 12 months
6 secondary outcomes
Evaluation of the benefit of everolimus introduction on renal function at 24 months
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on safety
Time frame: 24 months
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 20 Jun 2017.
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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.
Pascale BOISSONNAT, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing everolimus in people with Cardiac Transplantation and Chronic Renal Insufficiency, run by Hospices Civils de Lyon 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 5 inclusion and 21 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 20 Jun 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease. (time frame: 12 months). 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 20 Jun 2017.