Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 15, 2006

Last Updated Date

August 11, 2009

Start Date ^ICMJE

August 2006

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Superiority of everolimus-based regimen in renal function as compared to continuation of CNI-based treatment at 11 months post randomization in liver transplant patients.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00378014 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary objectives are to assess the efficacy and safety of the two regimens at 11 months post randomization

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Liver Transplantation

Intervention ^ICMJE

Drug: everolimus
Drug: basiliximab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Completion Date

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: novartis

41 61 324 1111

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00378014

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study ID Numbers ^ICMJE

CRAD001HDE10

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP