Status:
COMPLETED
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 live...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00378014
Start Date
August 1 2006
End Date
January 1 2013
Last Update
February 6 2015
Active Locations (16)
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1
Novartis Investigative Site
Innsbruck, Austria, A-6020
2
Novartis Investigative Site
Vienna, Austria, A-1090
3
Novartis Investigative Site
Berlin, Germany, Germany, 13353
4
Novartis Investigative Site
Essen, Germany, 45147