MedTrace Logo

Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

NCT02118896 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2024-11-22

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

Conditions

  • Heart Transplantation
  • Liver Transplantation
  • Kidney Transplantation

Interventions

DRUG

FK506E

oral

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-24
Primary Completion
2009-10-07
Completion
2009-10-07

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

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 NCT02118896 on ClinicalTrials.gov