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

NCT00596557 | Completed Phase 4

• 1 other identifier: 004765
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting. The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

Conditions

Chronic Rejection of Cardiac Transplant

Keywords

Renal function, heart transplant, everolimus

Outcome Measures

Primary Outcomes (1)

• Evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.

  1 year

Secondary Outcomes (1)

• The occurrence of major adverse cardiovascular events

  1 year

Study Arms (1)

Everolimus, Immunosupression

EXPERIMENTAL

everolimus and reduced dose CNI: reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.

Drug: everolimus

Interventions

everolimus DRUG

reduced dose CNI (cyclosporine level of 50-100)with everolimus levels of 3-8.

Also known as: certican

Everolimus, Immunosupression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 year
• Signed informed consent
• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Cardiology Department, Rabin Medical Center

Petah Tikva, Petah Tikva, 49100, Israel

Location

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Tuvia Ben Gal, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2011
• Last Updated: July 29, 2011

Record last verified: 2011-07

Locations

IL (1)