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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status and phase

Unknown
Phase 4

Conditions

Cardiac Transplantion

Treatments

Drug: Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l
Drug: Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l

Study type

Interventional

Funder types

Other

Identifiers

NCT00159159
2003.325

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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