Cardiac TransplantionPhase 4NCT00159159
LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
A Phase 4 study testing Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l and Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l in people with Cardiac Transplantion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Primary Objective: Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose Secondary Objective: To evaluate the immunosuppressive efficacy and tolerance of the treatment Study Duration: Twelve months for each patient Study Treatment: Ciclosporine Group A: low dose >=… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Transplantion
- What is being tested?
- Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l and Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2004to not given
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient:
- Males or females, ages > 18 < 65.
- First cardiac transplant.
- Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
- Written informed consent.
- Donor:
- Cold ischemia duration < 6 hours
Who cannot join
- Recipient:
- Unstable hemodynamic status at randomization.
- Patient with assisted circulation, considered unstable.
- Serum creatinine > 250 µmol/l.
- Nursing or pregnant females.
- HIV positive.
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- PCR hepatitis C virus (HCV) positive or hepatitis B surface (Hbs) antigen positive (within 6 months prior to study).
- Multi-organ graft or retransplant.
- History of cancer (evolving, or within 5 years, except for epidermoid or basocellular localised cutaneous carcinoma).
- Use of any investigational product and/or participation in another clinical research study within the last 30 days prior to study entry.
- Any substance abuse or any psychiatric disorder
- Contra-indication to study treatments.
- Unable to introduce ciclosporine within 4 days after transplant.
- Donor:
- Known coronary pathology or cardiac disease.
- HBsAg positive or HCV positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant
Primary Objective:
- Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose
Read more
Secondary Objective:
- To evaluate the immunosuppressive efficacy and tolerance of the treatment
Study Duration:
Twelve months for each patient
Study Treatment: Ciclosporine
Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200 µg/l < T0 ciclosporinemia < 300 µg/l.
Study Visits:
One visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.
Associated Treatments:
- Mycophenolate (Cellcept®), 3g a day
- Corticoids, as used for transplanted patients
Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.
- Conditions
- Cardiac Transplantion
- Being tested
- Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l, Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l
- Keywords
- Cardiac Transplant, ciclosporine, immunosuppressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/lDrug
Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/lDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
Secondary outcomes (9)
Area under curve of creatinine at 12 months
Cystatin C level at 1, 2, 3, 6 and 12 months
Creatinine clearance at 6 and 12 months
Proteinuria and microalbuminuria at 6 and 12 months
Secondary outcomes include those linked to the immunosuppressive efficacy and tolerance of the treatment: Difference in appearance incidence of acute graft reject and adverse events
Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
Difference in the evolution of left ventricular function and cardiovascular risk factors between the two groups at 6 and 12 months versus baseline: left ventricular ejection fraction and shortening fraction (echocardiogram)
systolic and diastolic blood pressure
fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
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 TransplantionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Pascale BOISSONNAT, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159159
- Sponsor's protocol ID
- 2003.325
- Status last verified
- Apr 2007
- First submitted
- 8 Sep 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Publications
Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231.
PubMed 23206408
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant
- ClinicalTrials.gov ID
- NCT00159159
- Acronym / sponsor ID
- 2003.325
- Conditions
- Cardiac Transplantion
- Keywords
- Cardiac Transplant, ciclosporine, immunosuppressive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2004
- First posted
- 12 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.
Primary Objective:
- Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose
Secondary Objective:
- To evaluate the immunosuppressive efficacy and tolerance of the treatment
Study Duration:
Twelve months for each patient
Study Treatment: Ciclosporine
Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200 µg/l < T0 ciclosporinemia < 300 µg/l.
Study Visits:
One visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.
Associated Treatments:
- Mycophenolate (Cellcept®), 3g a day
- Corticoids, as used for transplanted patients
Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females, ages > 18 < 65.
- First cardiac transplant.
- Negative pregnancy test for females of childbearing potential, at screening. Efficient method of contraception must be used during the study.
- Written informed consent.
- Cold ischemia duration < 6 hours
Key exclusion criteria (16 listed)
- Unstable hemodynamic status at randomization.
- Patient with assisted circulation, considered unstable.
- Serum creatinine > 250 µmol/l.
- Nursing or pregnant females.
- HIV positive.
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 |
|---|---|---|
| Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l | Drug | – |
| Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l | Drug | – |
Primary outcome
Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
9 secondary outcomes
Area under curve of creatinine at 12 months
Cystatin C level at 1, 2, 3, 6 and 12 months
Creatinine clearance at 6 and 12 months
Proteinuria and microalbuminuria at 6 and 12 months
Secondary outcomes include those linked to the immunosuppressive efficacy and tolerance of the treatment: Difference in appearance incidence of acute graft reject and adverse events
Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
Difference in the evolution of left ventricular function and cardiovascular risk factors between the two groups at 6 and 12 months versus baseline: left ventricular ejection fraction and shortening fraction (echocardiogram)
systolic and diastolic blood pressure
fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
- Derived from this study: PubMed 23206408Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231.
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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 Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l and Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l in people with Cardiac Transplantion, 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 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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?
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?
Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level. 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 NCT00159159, 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 27 Apr 2007.