LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant - Full Text View

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00159159

Purpose

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.

Condition	Intervention	Phase
Cardiac Transplantion	Drug: Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l Drug: Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l	Phase IV

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Dose Comparison, Parallel Assignment
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

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	106
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159159

Locations

France
Pascale BOISSONNAT
Lyon, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Pascale BOISSONNAT, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2003.325
Study First Received:	September 8, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00159159
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Cardiac Transplant
ciclosporine
immunosuppressive

Study placed in the following topic categories:

Mycophenolate mofetil

ClinicalTrials.gov processed this record on January 14, 2009