PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study 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 recipients - PROTECT

• Register: EUCTR
• Last refreshed on: 27 May 2013
• Main ID: EUCTR2005-002920-32-AT
• Date of registration: 22/12/2005
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study 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 recipients - PROTECT
• Scientific title: PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study 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 recipients - PROTECT
• Date of first enrolment: 26/01/2006
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002920-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Germany, Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:
The investigator must ensure that each patient meet all the following inclusion criteria at study entry:
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
Are the trial subjects under 18?
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:
The patient meeting any of the following criteria will be excluded from the study participation:
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 (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

prophylaxis of organ rejections in adult patients after liver transplantation

Intervention(s)

Trade Name: Certican 0.5 mg Tabletten
Product Name: Certican Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Trade Name: Certican 0.75 mg Tabletten
Product Name: Certican Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.75-

Trade Name: Simulect
Product Name: Simulect
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Basiliximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): renal function assessed by glomerular filtration rate (GFR)

Secondary Objective: The secondary objectives are to assess the efficacy and safety of the two regimens. This will be evaluated at 11 months post randomization by the comparison between the two groups of:
• Incidence of efficacy failure (defined as the combined endpoint of Biopsy Proven Acute Rejection, graft loss, death, lost to follow up from any reason)
• Incidence of the need for a change in the immunosuppressive regimen other than described in the protocol
• Incidence of renal deterioration defined as a decrease >/= 25% in cGFR (Cockcroft-Gault) compared to start of randomized treatment
• Renal function after five months post randomization. Renal function is measured as cGFR (Cockcroft-Gault)
• Incidence of treated Biopsy Proven Acute Rejection
• Patient and graft survival
• HCV replication in HCV positive patients
• Safety parameters including hypertension, diabetes mellitus (fasting glucose), hyperlipidemia, anemia, infections and malignancies

Main Objective: The primary objective is to show superiority of Certican®-based regimen with discontinuation of initial CNI therapy in renal function as compared to continuation of CNI based treatment at 11 months post randomization in liver transplant patients. This will be evaluated by comparing renal function calculated by glomerular filtration rate (cGFR) (Cockcroft-Gault formula) between the two groups of patients.

Secondary ID(s)

CRAD001HDE10