Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

This study is currently recruiting participants.

Verified by Novartis, August 2009

First Received: September 15, 2006 Last Updated: August 11, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00378014

Purpose

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.

Condition	Intervention	Phase
Liver Transplantation	Drug: everolimus Drug: basiliximab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Everolimus Basiliximab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	August 2006
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: everolimus certican
2: Active Comparator	Drug: basiliximab

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378014

Contacts

Contact: novartis

41 61 324 1111

Locations

Germany
Universitaetsklinikum Regensburg	Recruiting
Regensburg, Germany, 93053
Contact: Hans Jürgen Schlitt, Prof. Dr. 49- 941-944 680
Principal Investigator: Hans Jürgen Schlitt, Prof. Dr

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001HDE10
Study First Received:	September 15, 2006
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00378014 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Novartis:

Liver transplantation, everolimus

Additional relevant MeSH terms:

Everolimus
Basiliximab
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009