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

• Conditions: de novo heart transplantation; MedDRA version: 8.1Level: LLTClassification code 10019314Term: Heart transplant

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-17
• Last Update Posted: 1 May 2012

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.
• Women of childbearing potential should have a negative serum or urine pregnancy
test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning
therapy. Females are eligible if they are postmenopausal for at least 24 months past
last natural menses. Study medication should not be administered until a negative
pregnancy test report is obtained. Two or more acceptable methods of contraception
should be started 1 month prior to beginning study drug unless abstinence is the
chosen method, during therapy, and for 3 months after stopping the study.
Abstinence is an allowed contraceptive method if in the judgment of the investigator the patient is reliably abstaining. Celibate members of religious orders (like nuns,
priests, etc...) will be considered in consultation with the local Novartis Medical
Advisor on a case by case basis. Although there may be local/ country specific
differences, acceptable forms of birth control include any two or more of the
following methods: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy),
hormonal contraception (implantable, patch, oral), IUD and barrier methods (male
or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic
abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and
withdrawal are not acceptable methods of contraception.

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/mm3 at the evaluation before randomization.
•Patients who are recipients of multiple solid organ ro tissues transplants or have previously received organ transplants.
•Patients who are recipients of ABO incompatible transplants
•Patients with clinically significant systemic infection at time of transplant or within 2 weeks prior to transplant
•Patients receiving investigational drug or who have been treated with a non-protocol immunosuppresive drug or treatment within 1 months prior to randomisation.
•Patients receiving induction therapy in non induction center
•Patients not receiving induction therapy in an induction center
•Induction therapy other than Simulect or thymoglobulin
•Patients at Simulect resp. thymoglobulin induction therapy receiving an induction therapy that is not Simulect rsp. thymoglobulin
•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 been tested positive for HIV or Hepatitis C or are positive for Hepatitis B surface AG. Laboratory results obtained within 6 months prior to study entry are acceptable; otherwise these tests should be performed within 1 week after randomisation
•Recipients of organs from donors who test positive for Hepatitis B surface AG or Hepatitis C
•Patients being treated with terfenadine, astemizole, or cisapride
•Patients with any past history (within the past 5 years) or present malignancy, whether or not there is evidence of local recurrence or metastases (other than excised non-melanoma skin lesions)
•Patients with a known hypersensitivity to drugs of this class.
•Patients with donor greater than 65 years and/or with known donor coronary or 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 by mouth (short-term NG administration allowed not longer than Day 5).
•Existence of any surgical or medical condition significantly altering ADME of study medication; and/or presence of severe diarrhea or active peptic ulcer.
•abnormal physical or laboratory findings of clinical significance with 2 weeks of randomisation interfering with the objectives of the study
•Femals of childbearing potential planning to become pregnant, being pregnant and/or lactating, unwilling to use effective means of contraception
•Females of childbearing potential who are planning to become pregnant, who are
pregnant and/or lactating, who are unwilling to use at least two effective means of
contraception.

Study & Design

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