Cardiac TransplantationPhase 3NCT00170794
Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
A Phase 3 study testing Everolimus (RAD001) in people with Cardiac Transplantation, run by Novartis Pharmaceuticals.
Trial summary
The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Transplantation
- What is being tested?
- Everolimus (RAD001)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2004to Jul 2006
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female cardiac transplant recipients, 18-70 years old, with established cardiac allograft vasculopathy or at risk to develop a cardiac allograft vasculopathy.
- Patients who are more than 12 months post-transplant and who are receiving a cyclosporine microemulsion-based immunosuppressive regimen with/without azathioprine /mycophenolate mofetil, with/without steroids.
- Patients need to have stable renal function with a calculated GFR exceeding 40 ml/min (Nankivell).
- Patients without a biopsy-proven acute rejection ≥ grade 2, within 12 months prior to study entry.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 4 weeks following discontinuation of the study medication, even where there has been a history of infertility.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Patients who are recipients of multiple solid organ transplants.
- Patients with a calculated GFR of less than 40 ml/min.
- Patients with a biopsy-proven acute rejection episode ≥ 2 within 12 months prior to study entry.
- Patients who had received any investigational drug within 4 weeks prior to study entry.
- Patients currently being treated with sirolimus or having a history of prior therapy or having a hypersensitivity to drug similar to everolimus.
- Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of ≤ 2,500/mm3 or with a hemoglobin value < 10 g/dL.
Show all 15Show fewer
- Presence of severe hypercholesterolemia (≥ 9.1 mmol/L) or hypertriglyceridemia (≥ 8.55 mmol/L).
- Patient with NYHA class IV heart failure, or with left ventricular ejection fraction <30%. Patients with life-threatening cardiac allograft vasculopathy and/or graft dysfunction (life expectancy 1 year).
- Patients with severe systemic infections.
- Patients who are known to have HBsAg or HCV positive hepatitis, or who are HIV positive. Serology results obtained within 6 months prior to study entry are acceptable. If results cannot be obtained prior to study entry, a sample must be retained for later analysis. This stored sample will be destroyed at the end of study.
- Patients with any past (within the last 5 years) or present malignancy other than non-melanotic skin cancer.
- Existence of a co-morbid condition likely to result in death prior to study completion
- Symptoms of significant mental illness, which in the opinion of the investigator may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
- Inability to cooperate or communicate with the investigator.
- Female patients of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
About this study
Official title: A One Year, Multicenter, Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.
- Conditions
- Cardiac Transplantation
- Being tested
- Everolimus (RAD001)
- Keywords
- cardiac transplantation, everolimus, cyclosporine microemulsion, GFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus (RAD001)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.
Secondary outcomes (5)
Incidence of acute rejection episode greater than or equal to grade 3A.
Safety laboratory tests including lipid profiles, hematology and proteinuria.
Incidence of premature study treatment discontinuation.
Incidence of serious adverse avents (SAEs).
Incidence of admission to the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170794
- Sponsor's protocol ID
- CRAD001A2412
- Status last verified
- Nov 2016
- First submitted
- 9 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Ross H, Pflugfelder P, Haddad H, Cantarovich M, White M, Ignaszewski A, Howlett J, Vaillancourt M, Dorent R, Burton JR; CADENCE Study Group (CAnadian Pilot Sutdy to Determine Safe and Effective Dosing of Neoral and CErtican in Stable Cardiac Transplant Recipients). Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study. Transpl Int. 2010 Jan;23(1):31-7. doi: 10.1111/j.1432-2277.2009.00940.x.
PubMed 20050127
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year, Multicenter, Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
- ClinicalTrials.gov ID
- NCT00170794
- Acronym / sponsor ID
- CRAD001A2412
- Conditions
- Cardiac Transplantation
- Keywords
- cardiac transplantation, everolimus, cyclosporine microemulsion, GFR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2006 (actual)
- First posted
- 15 Sep 2005 (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 purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female cardiac transplant recipients, 18-70 years old, with established cardiac allograft vasculopathy or at risk to develop a cardiac allograft vasculopathy.
- Patients who are more than 12 months post-transplant and who are receiving a cyclosporine microemulsion-based immunosuppressive regimen with/without azathioprine /mycophenolate mofetil, with/without steroids.
- Patients need to have stable renal function with a calculated GFR exceeding 40 ml/min (Nankivell).
- Patients without a biopsy-proven acute rejection ≥ grade 2, within 12 months prior to study entry.
- Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 4 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Key exclusion criteria (15 listed)
- Patients who are recipients of multiple solid organ transplants.
- Patients with a calculated GFR of less than 40 ml/min.
- Patients with a biopsy-proven acute rejection episode ≥ 2 within 12 months prior to study entry.
- Patients who had received any investigational drug within 4 weeks prior to study entry.
- Patients currently being treated with sirolimus or having a history of prior therapy or having a hypersensitivity to drug similar to everolimus.
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 |
|---|---|---|
| Everolimus (RAD001) | Drug | – |
Primary outcome
Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.
5 secondary outcomes
Incidence of acute rejection episode greater than or equal to grade 3A.
Safety laboratory tests including lipid profiles, hematology and proteinuria.
Incidence of premature study treatment discontinuation.
Incidence of serious adverse avents (SAEs).
Incidence of admission to the hospital.
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 18 Nov 2016.
- Results publication: PubMed 20050127Ross H, Pflugfelder P, Haddad H, Cantarovich M, White M, Ignaszewski A, Howlett J, Vaillancourt M, Dorent R, Burton JR; CADENCE Study Group (CAnadian Pilot Sutdy to Determine Safe and Effective Dosing of Neoral and CErtican in Stable Cardiac Transplant Recipients). Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study. Transpl Int. 2010 Jan;23(1):31-7. doi: 10.1111/j.1432-2277.2009.00940.x.
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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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus (RAD001) in people with Cardiac Transplantation, run by Novartis Pharmaceuticals.
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 15 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 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00170794, which also lists 1 linked publication.
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 18 Nov 2016.