Transplant Recipients MedDRA version: 7.0 Level: LLT Classification code 10061890
Conditions
Interventions
Trade Name: Advagraf 0.5 mg - prolonged release hard capsules
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-03
Current Sponsor code: FK506
Sponsors
Astellas Pharma Europe Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Pregnant women or nursing mothers 2. Women unwilling or unable to use adequate contraception during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland, Hungary
Outcome results
None listed