A Study of Safety, Tolerability & Efficacy of Certican in de novo Heart Transplant (Tx) Patients

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy. This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Official Title

Conditions

Heart transplantation

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcomes: To determine whether Neoral dose optimization can improve renal function in de novo heart recipients receiving Neoral in addition to Everolimus; This will be assessed by comparing renal function post-transplant between 2 groups of patients.

Study Start

August 2004

Eligibility & Criteria

Inclusion Criteria:- Male or female cardiac patients 18-65 years old – Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment – Patients who are willing and able to participate in the full course of the study and for whom written informed consent has been obtained Exclusion Criteria:- Patients with serum creatinine level higher than 250 micromol/L at baseline – Patients with platelet count less or equal than 50,000/mm3 or with a WBC of less or equal than 2,500/mm3 at baseline – Presence of severe hypercholesterolemia (higher or equal to 350mg/dL) or hypertriglyceridemia (higher or equal to 750mg/dL)

Total Enrolment

Contact Details

[1] Fabienne Veuillez, PharmD, PhD ++4161 324 80 57 fabienne.veuillez@pharma.novartis.com [2] St Vincent Hospital, Darlinghurst, NSW2010, Australia; Not yet recruiting Christopher S Hayward ++61 2 8382 1111 Peter S MacDonald ++61 2 8382 1111 PSMACDONALD@STVINCENTS.COM.AU Anne Keogh, Prof, Principal Investigator[3] The Prince Charles Hospital, Chermside, Queensland, 4032, Australia; Recruiting George Javorsky, MD ++ 07 3350 8111 Jo Maddicks-Law ++ 07 3350 8111 Deborah Meyers, MD, Principal Investigator