Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00378014
First received: September 15, 2006
Last updated: July 12, 2013
Last verified: July 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: everolimus
certican
Other Name: certican
Active Comparator: 2 Drug: basiliximab
Other Name: simulect

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
Germany
Universitaetsklinikum Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00378014     History of Changes
Other Study ID Numbers: CRAD001HDE10
Study First Received: September 15, 2006
Last Updated: July 12, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Novartis:
Liver transplantation, everolimus

Additional relevant MeSH terms:
Everolimus
Sirolimus
Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 20, 2014