Clinical trial NCT00378014: Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
Official title: Presentation 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Liver transplantation, everolimus, CNI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-19
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.


Eligibility criteria: Inclusion Criteria:

* Males or females 18 - 70 years old
* Liver transplant recipient (living or deceased donor)
* Patients in whom an allograft biopsy will not be contraindicated

Exclusion Criteria:

* Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
* HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
* HIV positive patients
* Patients who are breast feeding
* Patients with a current severe systemic infection
* Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
* 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)
* Patients that have received Simulect prior to this study.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Calculated Glomerular Filtration Rate (cGFR)
timeFrame: Month 11
Secondary outcomes:
measure: Incidence of Efficacy Failure
timeFrame: Month 11
measure: Incidence of the Need for a Change in the Immunosuppressive Regimen
timeFrame: Month 11
measure: Incidence of Renal Deterioration
timeFrame: Baseline, Month 11
measure: Renal Function (cGFR)
timeFrame: Month 5
measure: Incidence of Treated BPAR
timeFrame: Month 11
measure: Patient and Graft Survival
timeFrame: Month 11
measure: Hepatitis C Virus (HCV) Replication in HCV-positive Patients
timeFrame: Baseline, Month 5
measure: Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
timeFrame: From randomization to Month 11
measure: Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
timeFrame: Month 12 to Month 59 post-baseline
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Genève
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: