Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00596557
• Date of registration: 08/01/2008
• Primary sponsor: Rabin Medical Center
• Public title: Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up CRAD001AILO2
• Scientific title: Phase IV: Effect of Everolimus and CNI Minimalization on Renal Function.
• Date of first enrolment: February 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00596557
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Countries of recruitment

Israel

Contacts

• Name: Tuvia Ben Gal, MD
• Affiliation: Rabin Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 year

- Signed informed consent

- 6 months to 15 year after heart transplantation

- Stable heart allograft function without rejection for at least 12 months

- Same immunusuppressive drugs for at least 3 months

- CNI based immunusuppression, with Cyclosporin levels C0 100-200 ng/ml FK levels of
5-10 ng/ml for preserved CNI levels.

- Poor renal function: creatinine > 1.5 mg%.

Exclusion Criteria:

- Suspected non-compliance

- Intolerance to Everolimus

- Life expectancy < 1year

- Proteinuria > 1.5 g/24u/1.73m2

- Previous sirolimus treatment

- Patients who received any other investigational drug

- Patients with platelet count <50,000/mm³ before baseline.

- Presence of severe hypercholesterolemia (=350 mg/dL; =9 mmol/L) or
hypertriglyceridemia (=750 mg/dL; =8.5 mmol/L)

- Patients with an absolute neutrophil count of = 1,500/mm3 or white blood cell count
of = 4000/mm³ at baseline

- Patients with a known hypersensitivity to similar drugs and to the components of the
formulations

- Patients being treated with terfenadine, astemizole, or cisapride.

- Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450
3A4.

- Patients with any past (within the past 5 years) or present malignancy (other than
excised basal cell carcinoma)

- Patients with clinically significant systemic infection.

- Existence of any surgical or medical condition, which in the opinion of the
investigator, might significantly alter the absorption, distribution, metabolism and
excretion of study medication, and/or the presence of severe diarrhea or active
peptic ulcer.

- Females of childbearing potential who are planning to become pregnant, who are
pregnant and/or lactating, who are unwilling to use effective means of contraception.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Rejection of Cardiac Transplant

Intervention(s)

Drug: everolimus

Primary Outcome(s)

Evolution of renal function after initiation of Everolimus and minimalisation of CNI dose. [Time Frame: 1 year]

Secondary Outcome(s)

The occurrence of major adverse cardiovascular events [Time Frame: 1 year]

Secondary ID(s)

004765

Source(s) of Monetary Support

Please refer to primary and secondary sponsors