Kidney DysfunctionPhase 4NCT00420537
Shift to Everolimus (RAD) Kidney Sparing Study
A Phase 4 study testing cyclosporine, Mycophenolate mofetil and Everolimus in people with Kidney Dysfunction and Heart Transplantation, run by University of Bologna at 1 site in Italy.
Trial summary
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Dysfunction, Heart Transplantation
- What is being tested?
- cyclosporine, Mycophenolate mofetil and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2006to Mar 2009
- 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
- Heart Transplant with 1 to 4 years of follow-up
- GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)
Who cannot join
- Acute rejection in the previous 6 months
- Contraindications to statin therapy
- Ongoing infection
- Ongoing heart failure
- Myocardial infarction or myocardial revascularization after transplant
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients
The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
- Conditions
- Kidney Dysfunction, Heart Transplantation
- Being tested
- cyclosporine, Mycophenolate mofetil, Everolimus
- Keywords
- Kidney, Heart Transplantation, Creatinine, Glomerular Filtration Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
cyclosporine trough levels between 100 and 150
cyclosporineDrug
cyclosporine trough levels between 40 and 90 ng/ml
mycophenolate with low doses
EverolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate | Active comparator | Mycophenolate mofetil with cyclosporine trough levels between 100 and 150 Receives: Drug: cyclosporine; Drug: Mycophenolate mofetil |
| Everolimus | Active comparator | Everolimus with cyclosporine trough levels between 40 and 90 ng/ml Receives: Drug: cyclosporine; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated GFR
Measured: One year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: A cluster of adverse events in everolimus arm was noted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney DysfunctionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Investigators
- Angelo Branzi, MD, Study chair, Alma Mater Studiorum University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420537
- Sponsor's protocol ID
- 2006-003035-78
- Status last verified
- May 2009
- First submitted
- 9 Jan 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
Publications
Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. doi: 10.1016/j.transproceed.2005.10.005.
PubMed 16387066Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171.
PubMed 12944570
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Low-dose Cyclosporine in Association With Everolimus to Minimize Renal Dysfunction in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT00420537
- Acronym / sponsor ID
- 2006-003035-78
- Conditions
- Kidney Dysfunction, Heart Transplantation
- Keywords
- Kidney, Heart Transplantation, Creatinine, Glomerular Filtration Rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A cluster of adverse events in everolimus arm was noted.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Jan 2007 (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 this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycophenolate | Active comparator | Drug: cyclosporine, Drug: Mycophenolate mofetilMycophenolate mofetil with cyclosporine trough levels between 100 and 150 |
| Everolimus | Active comparator | Drug: cyclosporine, Drug: EverolimusEverolimus with cyclosporine trough levels between 40 and 90 ng/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Heart Transplant with 1 to 4 years of follow-up
- GFR between 20 and 60 ml/min (calculated with Colkoroft-Gault formula)
Key exclusion criteria (6 listed)
- Acute rejection in the previous 6 months
- Contraindications to statin therapy
- Ongoing infection
- Ongoing heart failure
- Myocardial infarction or myocardial revascularization after transplant
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 |
|---|---|---|
| cyclosporinecyclosporine trough levels between 100 and 150 | Drug | mycophenolate |
| cyclosporinecyclosporine trough levels between 40 and 90 ng/ml | Drug | Everolimus |
| Mycophenolate mofetilmycophenolate with low doses | Drug | mycophenolate |
| Everolimus | Drug | Everolimus |
Primary outcome
Calculated GFR
Time frame: One year after randomization
Results and safety
The study was stopped early (reason given: A cluster of adverse events in everolimus arm was noted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Background: PubMed 16387066Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. doi: 10.1016/j.transproceed.2005.10.005.
- Background: PubMed 12944570Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171.
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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.
Angelo Branzi, MD study chair
Alma Mater Studiorum University of Bologna
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 cyclosporine, Mycophenolate mofetil and Everolimus in people with Kidney Dysfunction and Heart Transplantation, run by University of Bologna at 1 site in Italy.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Jan 2010. 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 Italy. 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 was stopped early (reason given: A cluster of adverse events in everolimus arm was noted.). Results are not available in the source record.
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?
Calculated GFR (time frame: One year after randomization). 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 NCT00420537, which also lists 2 linked publications.
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 12 Jan 2010.