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Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

NCT01011205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 893

Last updated 2024-11-01

No results posted yet for this study

Summary

Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.

Conditions

  • Liver Transplantation

Interventions

DRUG

Advagraf

Capsule

DRUG

Mycophenolate Mofetil

Solution for infusion

DRUG

Basiliximab

IV infusion

DRUG

Corticosteroids

IV bolus

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma Global Development - EU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-01-04
Completion
2013-01-04

Countries

  • Argentina
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Poland
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011205 on ClinicalTrials.gov