Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in recently liver transplanted recipients
- Conditions
- de novo liver transplant recipients, immunosuppressive treatmentTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2015-002935-16-DE
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
1.Ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related proce-dures.
2.Male or female recipients = 18 years of a liver graft from a deceased or living donor
3.The patient must receive a twice dailyTacrolimus based immunosuppression treatment.
4.Females of child-bearing potential who agree to comply with any applicable contraceptive re-quirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization).
5.Non-pregnant, non-lactating female.
6.Recipients of a first or re-liver transplant in the last 30 days
7.The patient is co-operative and available for the entire clinical trial.
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1.1.Patients with a known hypersensitivity to any of the drugs used in the study.
2.Patients who are not able to take oral medication at the time point of randomization.
3.Recipients of combined organ transplants.
4.Patients who are recipients of AB0 incompatible transplant grafts.
5.Currently participation in a clinical trial and any IMP intake within the last four weeks.
6.Patients who use drugs known to strongly interact with the cytochrome P-450 3A4 pathway and therefore influence the tacrolimus blood level are not allowed during Envar-sus®/Advagraf® treatment period.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To assess the equivalent dose of Envarsus® to achieve the same target trough level as achieved with Advagraf and to assess the conversion ratios Envarsus® ? Advagraf®.<br> ;<br> Secondary Objective: To compare the pharmacokinetic (PK) profile and bioavailability of two different once daily tacrolimus formulations (Envarsus® versus Advagraf®) in de novo liver transplant recipients.<br> The extent and rate of Tacrolimus exposure will be estimated in terms of trough level C0, area under the curve AUC and the Highest concentration determined in the measuring interval (Cmax) respectively.<br> To compare the safety profile (Frequency and severity of Adverse Events (AEs))<br> ;Primary end point(s): Dav , C0/dosei , AUC0-24/dosei;Timepoint(s) of evaluation of this end point: end of the trial
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): C0, AUC0-24, Cmax, tmax, PTF, Cmax/dosei<br> Nadj (No. of dose adjustment steps required for a stable C0)<br> ;Timepoint(s) of evaluation of this end point: end of the trial