Cardiac Transplantion
Conditions
Keywords
Cardiac Transplant, ciclosporine, immunosuppressive
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.
Interventions
DRUGCiclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l
DRUGCiclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| Cystatin C level at 1, 2, 3, 6 and 12 months | — |
| 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 | — |
| Area under curve of creatinine at 12 months | — |
Countries
France
Outcome results
None listed