Status:
UNKNOWN
LOW CYCLO: Study Evaluating the Benefit of Two Doses of Ciclosporine in de Novo Cardiac Transplant
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cardiac Transplantion
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00159159
Start Date
March 1 2004
Last Update
April 27 2007
Active Locations (1)
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1
Pascale BOISSONNAT
Lyon, France, 69677