Heart transplantation MedDRA version: 16.1 Level: PT Classification code 10019314 Term: Heart transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Certican
Product Name: Certican
Product Code: RAD001
Pharmaceutical Form: Tablet
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Sponsors
Novartis Norge AS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 9 mmol/l and or triglycerides (TG) >6 mmol/l despite lipid lowering treatment 7.Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator 8.Patient with a current clinically severe systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy between treatment regimes by assessing the difference in renal function evaluated by measured glomerular function rate (mGFR) 12 months after heart transplantation (HTX). ;Secondary Objective: To compare the efficacy between treatment regimens by assessing the difference in -Progression of chronic allograft vasculopathy (CAV) assessed by intravascular ultrasound (IVUS) examination -Renal function; change of GFR from visit 5 (week 7-11) to Month 12 -Renal function; cGFR (MDRD formula) at each follow-up visit -Number of rejections -Occurrence of treatment failures up to or at 12 months -Development and magnitude of proteinuria -Lipid profile at 12 months -Quality of Life assessed by SF-36, EQ 5D and Becks -Hemodynamic variables -Left ventricular function -Optional: Working capacity (Peak oxygen uptake at week 7 and month 12) -Metabolic parameters -Inflammatory variables -Safety and tolerability -Optional: Measurements of microvascular circulation in connection to the IVUS examinations ;Primary end point(s): •Measured Glomerular Filtration Rate (mGFR),Cr-EDTA clearance at week 7-11 and at 12 months •Development of CAV : Intravascular Ultrasound (IVUS) and Virtual Histology (VH) •Number of rejections •Number of treatment failures | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed