Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 7:47 AM
Study NCT ID:
NCT00159159
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: