This trial is active, not recruiting.

Condition cardiac transplantion
Treatments ciclosporine 130 µg/l < t0 ciclosporinemia < 200 µg/l, ciclosporine 200 µg/l < t0 ciclosporinemia < 300 µg/l
Phase phase 4
Sponsor Hospices Civils de Lyon
Start date March 2004
Trial size 106 participants
Trial identifier NCT00159159, 2003.325


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label

Primary Outcomes

Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
time frame:

Secondary Outcomes

Area under curve of creatinine at 12 months
time frame:
Cystatin C level at 1, 2, 3, 6 and 12 months
time frame:
Creatinine clearance at 6 and 12 months
time frame:
Proteinuria and microalbuminuria at 6 and 12 months
time frame:
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
time frame:
Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
time frame:
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)
time frame:
systolic and diastolic blood pressure
time frame:
fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Pascale BOISSONNAT, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.