A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®) and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy. - SCHEDULE

• Conditions: Heart transplantation; MedDRA version: 14.1Level: PTClassification code 10019314Term: Heart transplantSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-013074-41-DK
• Lead Sponsor: ovartis Healthcare A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-25
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

To be fulfilled at the time of transplantation and before entering period 1 of the study
- Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
- Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months
- Patients received induction therapy with ATG (Thymoglobulin)

At time of entering period 2:
- Patients completed period 1 on the maintained immunosuppressive regimen they were randomized to within the target doses and levels specified for each group.
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

To be fulfilled at the time of transplantation and before entering period 1 of the study
1.Recipient of multi-organ transplants or previously transplanted organs
2.Patients with donor greater than 70 years
3.Donor heart cold ischemic time > 6 hours.
4.Patients who are recipients of ABO incompatible transplants
5.Patients with platelet count < 50,000/mm3 at the evaluation before transplantation
6.Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation
7.Patient with a known hypersensitivity to cyclosporine
8.Patient with a current severe systemic infection
9.Patient unable to participate in the study for the full 12-month period
10.Presence of severe hypercholesterolemia (= 350 mg/dL; = 9 mmol/L) or hypertriglyceridemia (= 750 mg/dL; = 8.5 mmol/L)
11.Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
12.Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
13.Patients with HIV, hepatitis B or C

At time of entering period 2:
1. Graft loss
2.Patients with ongoing treatment for rejection
3. Patients that have experienced a biopsy proven ISHLT grade 3R rejection or two or more grade 2R rejections during period 1
4. Patients who have experienced a humoral (antibody mediated) rejection with a hemodynamic compromise during period 1).
5.Patients with a hemoglobin count < 8,0 g/l (5.0 mmol/l); and/or a platelet count < 50 x 109/l and/or white blood cell count < 2.5 x 109/l)
6.Patients with total cholesterol (TC) >9 mmol/l and or triglycerides (TG) >6 mmol/l despite lipid lowering treatment
7.Patients with a spot urinary protein/creatinine or albumin/creatinine ratio > 100 mg/mmol
8.Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
9.Patient with a current clinically severe systemic infection

Study & Design

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