Clinical trial NCT00451932: A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
Official title: A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplantation
Keywords: Malononitrilamide
Immunosuppression
treatment efficacy
treatment effectiveness
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-03-26
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 18 years of age and not older than 65 years.
* Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
* Male patients must agree to practice effective birth control methods during the study.
* Patient is a recipient of a primary whole cadaveric liver transplant

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a liver.
* Patient has received an ABO incompatible donor liver.
* Patient or donor is known to be HIV positive.
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
* Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
* Patient who is receiving or may require warfarin or fluvastatin during the study.
* Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant

Primary outcomes:
measure: Event rate of biopsy-proven acute rejections
Secondary outcomes:
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Brno
country: Czech Republic
city: Prague
country: Czech Republic
city: Clichy
country: France
city: Lyon Cedex 3
country: France
city: Lyon Cedex 4
country: France
city: Montpellier Cedex 5
country: France
city: Rennes Cedex
country: France
city: Strasbourg
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Budapest
country: Hungary
city: Milano
country: Italy
city: Udine
country: Italy
city: Rotterdam
country: Netherlands
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
city: Zurich
country: Switzerland
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Universitätsklinik Charité
name: Use Central Contact
role: PRINCIPAL_INVESTIGATOR
References: