A LONG-TERM FOLLOW UP STUDY TO EVALUATE THE SAFETY AND EFFICACY IN TRANSPLANT RECIPIENTS TREATED WITH MODIFIED RELEASE TACROLIMUS, FK506E (MR4); BASED IMMUNOSUPPRESSION REGIMEN - Extension Study
- Conditions
- Transplant RecipientsMedDRA version: 7.0Level: LLTClassification code 10061890
- Registration Number
- EUCTR2005-005714-20-FI
- Lead Sponsor
- Astellas Pharma Europe Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Patients who had already participated in the previous phase II PK or phase III studies with FK506E (MR4)
2. Patients capable of understanding the purpose and risks of the study, who have been fully informed and given written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Pregnant women or nursing mothers
2. Women unwilling or unable to use adequate contraception during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to assess the safety and efficacy of FK506E (MR4) as long-term treatment in transplant recipients who have participated in one of the phase II PK or phase III studies on FK506E (MR4) and have received at least one dose of study medication.;Secondary Objective: ;Primary end point(s): Patient and graft survival
- Secondary Outcome Measures
Name Time Method