Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objective:
Secondary Objective:
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:
Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l | Drug | |||
| Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of renal function, as assessed by the evolution between the two treatment groups at 12 months versus baseline serum creatinine level |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Recipient:
Donor:
Exclusion Criteria:
Recipient:
Donor:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pascale BOISSONNAT, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pascale BOISSONNAT | Lyon | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23206408 | Derived | Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D000602 |
| Amino Acids, Peptides, and Proteins |