Cardiac Transplantion Clinical Trial
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
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.
| Status | Active, not recruiting |
| Enrollment | 106 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Pascale BOISSONNAT | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level | |||
| Secondary | Area under curve of creatinine at 12 months | |||
| Secondary | Cystatin C level at 1, 2, 3, 6 and 12 months | |||
| Secondary | Creatinine clearance at 6 and 12 months | |||
| Secondary | Proteinuria and microalbuminuria at 6 and 12 months | |||
| Secondary | 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 | |||
| Secondary | Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades) | |||
| Secondary | 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) | |||
| Secondary | systolic and diastolic blood pressure | |||
| Secondary | fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides |