Clinical trial NCT01332201: Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Official title: A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Transplantation
Lung Transplantation
Pancreas (Including SPK) Transplantation
Keywords: Advagraf
Heart
Lung
Pancreas
Transplant
Immunosuppression
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 17
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: PREVENTION

Brief summary: Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.


Eligibility criteria: Inclusion Criteria:

* must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
* negative pregnancy test prior to enrolment (females)
* agree to practice effective birth control during the study
* treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (\<230 µmol/l (\<2.6 ml/dl)) on Day 1

Exclusion Criteria:

* receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
* pulmonary vascular resistance ≥4 Wood units despite medication
* required an emergency ventricular assist device within one week prior to transplantation
* significant renal impairment
* significant liver disease
* malignancies or a history of malignancy within the last 5 years
* significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
* requires systemic immunosuppressive medication for any other indication than transplantation
* diagnosis of cystic fibrosis
* pregnant or breast-feeding

Primary outcomes:
measure: determine steady state systemic exposure (AUC 0-24h)
timeFrame: Day 1, Day 3, Day 7 and Day 42
Secondary outcomes:
measure: determine Cmax (maximum concentration)
timeFrame: Day 1, Day 3, Day 7 and Day 42
measure: determine tmax (time to attain Cmax)
timeFrame: Day 1, Day 3, Day 7 and Day 42
measure: determine C24 (concentration prior to next morning dose)
timeFrame: Day 1, Day 3, Day 7 and Day 42
measure: describe rejection episodes
timeFrame: up to 58 weeks
measure: describe subject survival
timeFrame: up to 58 weeks
measure: describe graft survival
timeFrame: up to 58 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
city: Leuven
country: Belgium
city: Paris
country: France
city: Milan
country: Italy
city: Padova
country: Italy
city: Taipei
country: Taiwan
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Use Central Contact
role: STUDY_CHAIR
References: