Kidney DiseasesPhase 4SAREFUNCT00505102
Safe Renal Function In Long Term Heart Transplanted Patients
A Phase 4 study testing Everolimus in people with Kidney Diseases and Heart Transplantation, run by A.O. Ospedale Papa Giovanni XXIII at 2 sites in Italy.
Trial summary
The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Diseases, Heart Transplantation
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2007to Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Transplant patients with more than 1 year of follow-up
- Creatinine lower than 3.5 mg/dl
- GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
- Cyclosporine in maintenance immunosuppressive therapy
- Patient must be able to sign an approve informed consent
- Prior History of acute rejection within the last 3 months
- Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used
Who cannot join
- Patients who are recipients of multiple organ transplants
- Prior or current use of sirolimus or everolimus
- History of acute rejection within the last 6 months
- Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
- Patient not able to attend all follow-up evaluations
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Heart Transplant Center Ospedali Riuniti
Bergamo, 24100
Heart Transplantad Center OspedaliRiuniti Bergamo
Bergamo, 24100
About this study
Official title: Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
The purpose of this study is to verify whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy
- Conditions
- Kidney Diseases, Heart Transplantation
- Being tested
- Everolimus
- Keywords
- Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
cyclosporine dose reduced of 50% after introduction of everolimus
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
Measured: 2 years
Secondary outcomes (1)
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
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 DiseasesStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Investigators
- Roberto Fiocchi, MD PhD, Study director, Heart Transplant Center Ospedali Riuniti Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505102
- Sponsor's protocol ID
- SAREFU123
- Acronym
- SAREFU
- Status last verified
- Feb 2008
- First submitted
- 19 Jul 2007
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
PubMed 12954741Rothenburger M, Teerling E, Bruch C, Lehmkuhl H, Suwelack B, Bara C, Wichter T, Hinder F, Schmid C, Stypmann J. Calcineurin inhibitor-free immunosuppression using everolimus (Certican) in maintenance heart transplant recipients: 6 months' follow-up. J Heart Lung Transplant. 2007 Mar;26(3):250-7. doi: 10.1016/j.healun.2007.01.017.
PubMed 17346627
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Everolimus to SAve REnal Function (SAREFU) in Long Term Heart Transplanted Patients
- ClinicalTrials.gov ID
- NCT00505102
- Acronym / sponsor ID
- SAREFU / SAREFU123
- Conditions
- Kidney Diseases, Heart Transplantation
- Keywords
- Kidney Diseases, Heart Transplantation, Everolimus, Cyclosporine Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 20 Jul 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 whether the reduction of cyclosporine dosages associated with Everolimus administration may improve renal function as compared to patients maintained on standard immunosuppressive therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Everolimus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Heart Transplant patients with more than 1 year of follow-up
- Creatinine lower than 3.5 mg/dl
- GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
- Cyclosporine in maintenance immunosuppressive therapy
- Patient must be able to sign an approve informed consent
Key exclusion criteria (5 listed)
- Patients who are recipients of multiple organ transplants
- Prior or current use of sirolimus or everolimus
- History of acute rejection within the last 6 months
- Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
- Patient not able to attend all follow-up evaluations
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 |
|---|---|---|
| Everolimuscyclosporine dose reduced of 50% after introduction of everolimus | Drug | A |
Primary outcome
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin
Time frame: 2 years
1 secondary outcome
All cause mortality, infections, incidence of acute myocardial rejection, Heart Failure, Chronic Rejection, Mace
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2008.
- Background: PubMed 12954741Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
- Background: PubMed 17346627Rothenburger M, Teerling E, Bruch C, Lehmkuhl H, Suwelack B, Bara C, Wichter T, Hinder F, Schmid C, Stypmann J. Calcineurin inhibitor-free immunosuppression using everolimus (Certican) in maintenance heart transplant recipients: 6 months' follow-up. J Heart Lung Transplant. 2007 Mar;26(3):250-7. doi: 10.1016/j.healun.2007.01.017.
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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.
Roberto Fiocchi, MD PhD study director
Heart Transplant Center Ospedali Riuniti Bergamo
2 sites 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 Kidney Diseases and Heart Transplantation, run by A.O. Ospedale Papa Giovanni XXIII at 2 sites 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Renal function Evaluated measuring Creatinine, Creatinine Clearance (MDRD and Cockcroft-Gault) and Urinary excretion of Protein, albumin and alpha-1-microglobulin (time frame: 2 years). 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 NCT00505102, 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 13 Feb 2008.