A 24-month, multi-center, randomized, open-label non-inferiority study of efficacy and safety comparing two exposures of concentration-controlled Certican with reduced Neoral versus 3.0 g MMF with standard dose Neoral in de novo heart transplant recipients

Phase 1

• Conditions: de novo heart transplantation

• Registration Number: EUCTR2005-003413-32-DK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

• Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation.
• Patients who have given written informed consent to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Calculated creatinine clearance <40 ml/min at screening (MDRD Formula)
•Patients with platelet count <50,000/mm at the evaluation before randomization.
•Patients who are recipients of multiple solid organ transplants.
•Patients who are recipients of ABO incompatible transplants
•Patients with active systemic infection.
•Patients receiving drugs used for non-approved indications in the 30 days prior to study entry.
•Patients receiving induction therapy in non induction center
•Patients not receiving induction therapy in an induction center
•Induction therapy other than Simulect
•Presence of severe hypercholesterolemia (=?350 mg/dL; =?9 mmol/L) or hypertriglyceridemia (= 750 mg/dL; =?8.5 mmol/L) before randomization.
•Patients with an absolute neutrophil count of =?1,500/mm3 or white blood cell count of = 4000/mm3 at baseline before surgery
•Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed)
•Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.
•Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded
•Patients being treated with terfenadine, astemoizole, or cisapride
•Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
•Patients with a known hypersensitivity to drugs of this class.
•Patients with donor greater than 65 years and/or with known donor heart disease at the time of transplant.
•Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
•Cold ischemia time >6 hours.
•Unable to take oral medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified