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

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ClinicalTrials.gov Identifier: NCT00159159
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2005
Last Update Posted : April 27, 2007
Sponsor:
Information provided by:
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Cardiac Transplantion Drug: Ciclosporine 130 µg/l < T0 ciclosporinemia < 200 µg/l Drug: Ciclosporine 200 µg/l < T0 ciclosporinemia < 300 µg/l Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Area under curve of creatinine at 12 months
  2. Cystatin C level at 1, 2, 3, 6 and 12 months
  3. Creatinine clearance at 6 and 12 months
  4. Proteinuria and microalbuminuria at 6 and 12 months
  5. 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
  6. Myocardial biopsy (International Society of Heart and Lung Transplantation [ISHLT] grades)
  7. 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)
  8. systolic and diastolic blood pressure
  9. fasting glycemia, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00159159     History of Changes
Other Study ID Numbers: 2003.325
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Hospices Civils de Lyon:
Cardiac Transplant
ciclosporine
immunosuppressive

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors