Chronic Rejection of Cardiac TransplantPhase 4CRAD001AILO2NCT00596557
Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up
A Phase 4 study testing everolimus in people with Chronic Rejection of Cardiac Transplant, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rejection of Cardiac Transplant
- What is being tested?
- everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to Jul 2011
- 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
- Age ≥ 18 year
- Signed informed consent
- 6 months to 15 year after heart transplantation
- Stable heart allograft function without rejection for at least 12 months
- Same immunusuppressive drugs for at least 3 months
- CNI based immunusuppression, with Cyclosporin levels C0 100-200 ng/ml FK levels of 5-10 ng/ml for preserved CNI levels.
- Poor renal function: creatinine > 1.5 mg%.
Who cannot join
- Suspected non-compliance
- Intolerance to Everolimus
- Life expectancy < 1year
- Proteinuria > 1.5 g/24u/1.73m2
- Previous sirolimus treatment
- Patients who received any other investigational drug
Show all 16Show fewer
- Patients with platelet count <50,000/mm³ before baseline.
- Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L)
- Patients with an absolute neutrophil count of ≤ 1,500/mm3 or white blood cell count of ≤ 4000/mm³ at baseline
- Patients with a known hypersensitivity to similar drugs and to the components of the formulations
- Patients being treated with terfenadine, astemizole, or cisapride.
- Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
- Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
- Patients with clinically significant systemic infection.
- Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer.
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Cardiology Department, Rabin Medical Center
Petah Tikva, Petah Tikva, 49100
About this study
Official title: Phase IV: Effect of Everolimus and CNI Minimalization on Renal Function.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Read the detailed description
Everolimus is a new proliferation signal inhibitor with immunosuppressive and antiproliferative activity.
The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors.
Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
- Conditions
- Chronic Rejection of Cardiac Transplant
- Being tested
- everolimus
- Keywords
- Renal function, heart transplant, everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called certican
reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus, Immunosupression | Experimental | everolimus and reduced dose CNI: reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8. Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Measured: 1 year
Secondary outcomes (1)
The occurrence of major adverse cardiovascular events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rejection of Cardiac TransplantStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Tuvia Ben Gal, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596557
- Sponsor's protocol ID
- 004765
- Acronym
- CRAD001AILO2
- Status last verified
- Jul 2011
- First submitted
- 8 Jan 2008
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV: Effect of Everolimus and CNI Minimalization on Renal Function.
- ClinicalTrials.gov ID
- NCT00596557
- Acronym / sponsor ID
- CRAD001AILO2 / 004765
- Conditions
- Chronic Rejection of Cardiac Transplant
- Keywords
- Renal function, heart transplant, everolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jan 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.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Detailed description
Everolimus is a new proliferation signal inhibitor with immunosuppressive and antiproliferative activity.
The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors.
Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus, Immunosupression | Experimental | Drug: everolimuseverolimus and reduced dose CNI: reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 year
- Signed informed consent
- 6 months to 15 year after heart transplantation
- Stable heart allograft function without rejection for at least 12 months
- Same immunusuppressive drugs for at least 3 months
Key exclusion criteria (16 listed)
- Suspected non-compliance
- Intolerance to Everolimus
- Life expectancy < 1year
- Proteinuria > 1.5 g/24u/1.73m2
- Previous sirolimus treatment
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: certicanreduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8. | Drug | Everolimus, Immunosupression |
Primary outcome
Evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Time frame: 1 year
1 secondary outcome
The occurrence of major adverse cardiovascular events
Time frame: 1 year
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 29 Jul 2011.
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.
Tuvia Ben Gal, MD principal investigator
Rabin Medical Center
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 Chronic Rejection of Cardiac Transplant, run by Rabin Medical Center at 1 site in Israel.
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 7 inclusion and 16 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 29 Jul 2011. 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 Israel. 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?
Evolution of renal function after initiation of Everolimus and minimalisation of CNI dose. (time frame: 1 year). 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 29 Jul 2011.