A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Certican-based regimen versus calcineurin inhibitor-based regimen in de novo liver transplant recipient
- Conditions
- Therapy after Liver transplant10019654
- Registration Number
- NL-OMON30363
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Males or females 18 - 70 years old
2. Liver transplant recipient (living or deceased donor)
3. Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
4. Patients in whom an allograft biopsy will not be contraindicated
5. Females capable of becoming pregnant must have a negative pregnancy test prior to start of study and are required to practice a medically approved method of birth control for the duration of the study
6. Patients with cGFR > 50 ml/min
1. Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
2. HCV positive patients who need an active anti-viral treatment (HCV-positive patients without active antiviral treatment are allowed)
3. HIV positive patients
4. Patients who are breast feeding
5. Patients with a current severe systemic infection
6. Patients who have received an unlicensed drug or therapy within one month prior to study entry
7. Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
8. Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation.
9. Patients that have received Simulect prior to this study.
10. Patients that have received any immunosuppressive regimen 2 months prior to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>*to show superiority of Certican®-based regimen with discontinuation of initial<br /><br>CNI therapy in renal function as compared to continuation of CNI based<br /><br>treatment at 11 months post randomization in liver transplant patients. This<br /><br>will be evaluated by comparing renal function calculated by glomerular<br /><br>filtration rate (cGFR) (Cockcroft-Gault formula) between the two groups of<br /><br>patients</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the efficacy and safety of the two regimens, evaluated at 11 months<br /><br>post randomization by the comparison between the two groups of:<br /><br><br /><br>*Incidence of efficacy failure (defined as the combined endpoint of Biopsy<br /><br>Proven Acute Rejection, graft loss, death, lost to follow up from any reason)<br /><br>*Incidence of the need for a change in the immunosuppressive regimen other than<br /><br>described in the protocol<br /><br>*Incidence of renal deterioration defined as a decrease > = 25% in cGFR<br /><br>compared to start of randomized treatment<br /><br>*Renal function after five months post randomization. Renal function is<br /><br>measured as cGFR<br /><br>*Incidence of treated Biopsy Proven Acute Rejection<br /><br>*Patient and graft survival<br /><br>*HCV replication in HCV positive patients<br /><br>*Safety parameters including hypertension, diabetes mellitus (fasting glucose),<br /><br>hyperlipidemia, anemia, infections and malignancies</p><br>