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

NCT ID: NCT00159159

Last Updated: 2007-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

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.

Conditions

Cardiac Transplantion

Keywords

Cardiac Transplant; ciclosporine; immunosuppressive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l

Intervention Type: DRUG

Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Principal Investigators

Pascale BOISSONNAT, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Pascale BOISSONNAT

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 23206408 (View on PubMed)

Other Identifiers

2003.325

Identifier Type: -

Identifier Source: org_study_id