LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00159159|
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : April 27, 2007
- Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose
- To evaluate the immunosuppressive efficacy and tolerance of the treatment
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.
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.
- Mycophenolate (Cellcept®), 3g a day
- Corticoids, as used for transplanted patients
Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Transplantion||Drug: Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l Drug: Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2004|
- Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159159
|Lyon, France, 69677|
|Principal Investigator:||Pascale BOISSONNAT, MD||Hospices Civils de Lyon|