se of tacrolimus in heart transplant recipients
- Conditions
- Tacrolimus is a potent immunosuppressant agent widely used for the prevention and treatment of rejection in heart transplant recipients. While tacrolimus is typically administered in two divided doses per day, a new oral formulation with modified-release characteristics has recently been developed and licensed for use. Specifically formulated to enable once daily dosing, it was suggested that the benefit of the prolonged-release preparation maybe improved compliance.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-002097-13-SI
- Lead Sponsor
- Department of Cardiology, University Medical Centre Ljubljana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Patient inclusion criteria will consist of all of the following:
1.Presence of triple immunosuppressive regimen, consisting of standard tacrolimus formulation, mofetil mycophenolate and steroids
2.Absence of significant cellular of antibody-mediated rejection within 3 months before enrollment. Acute cellular rejection will defined in accordance with International Society for Heart and Lung Transplantation (ISHLT) grading system (7) and significant acute cellular rejection was defined as ISHLT grade 2R or higher. Antibody-mediated rejection (AMR) will be defined according to the ISHLT working formulation for pathologic diagnosis of AMR (8) with significant AMR defined as pAMR 2 or higher.
3.Absence of infection episodes within 3 months before enrollment. An infection episode (bacterial, viral, fungal or protozoal) will defined as any infection requiring at least 1 week of intravenous antibiotic therapy (9).
4.Absence of allograft dysfunction within 3 months before enrollment. Allograft dysfunction will be defined as left ventricular ejection fraction (LVEF) <40% on standard echocardiography.
5.Absence of CAV defined as ISHLT CAV grade 1 or higher (10).
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patient exclusion criteria will consist of any of the following:
1.Presence of significant cellular of antibody-mediated rejection within 3 months after enrollment (run-in phase).
2.Presence of infection episode within 3 months after enrollment (run-in phase).
3.Variability of C0 tacrolimus concentration >30% within 3 months after enrollment (run-in phase).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To compare tacrolimus concentration variability C0 of modified-release and standard tacrolimus formulations in heart transplant recipients.;Secondary Objective: - To compare the effects of modified-release and standard tacrolimus formulations on glucose metabolism in heart transplant recipients.<br>- To compare the effects of modified-release and standard tacrolimus formulations on renal function in heart transplant recipients.<br>- To evaluate the correlations between tacrolimus concentration variability and genotype in heart transplant recipients.<br>;Primary end point(s): Extended release tactolimus in non-inferior to standard release tacrolimus in C0 concentration variability in heart transplant recipients.;Timepoint(s) of evaluation of this end point: 3 monts after IMP initiation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Extended release tactolimus improves glucose metabolism in heart transplant recipients.<br>- Extended release tactolimus improves kidney function in heart transplant recipients.<br>- A correlation exists between specific genotypes of CYP3A5 and Co variability.;Timepoint(s) of evaluation of this end point: 3 monts after IMP initiation