Clinical trial NCT00159159: LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Transplantion
Keywords: Cardiac Transplant
ciclosporine
immunosuppressive
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 \>= 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Recipient:

* Unstable hemodynamic status at randomization.
* Patient with assisted circulation, considered unstable.
* Serum creatinine \> 250 µmol/l.
* Nursing or pregnant females.
* HIV positive.
* 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

Primary outcomes:
measure: Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
Secondary outcomes:
measure: Area under curve of creatinine at 12 months
measure: Cystatin C level at 1, 2, 3, 6 and 12 months
measure: Creatinine clearance at 6 and 12 months
measure: Proteinuria and microalbuminuria at 6 and 12 months
measure: 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
measure: Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
measure: 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)
measure: systolic and diastolic blood pressure
measure: fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
Other outcomes:
Locations:
city: Lyon
country: France
facility: Pascale BOISSONNAT
Study officials:
affiliation: Hospices Civils de Lyon
name: Pascale BOISSONNAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.