Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®

Phase 2

Completed

• Conditions: Heart Transplantation; Lung Transplantation; Pancreas (Including SPK) Transplantation
• Interventions: Drug: Advagraf; Drug: Prograf

• Registration Number: NCT01332201
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Study Start: 2011-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advagraf	Advagraf	-
Prograf	Prograf	-

Primary Outcome Measures

Name	Time	Method
determine steady state systemic exposure (AUC 0-24h)	Day 1, Day 3, Day 7 and Day 42

Secondary Outcome Measures

Name	Time	Method
describe graft survival	up to 58 weeks
determine Cmax (maximum concentration)	Day 1, Day 3, Day 7 and Day 42
describe subject survival	up to 58 weeks
determine C24 (concentration prior to next morning dose)	Day 1, Day 3, Day 7 and Day 42
determine tmax (time to attain Cmax)	Day 1, Day 3, Day 7 and Day 42
describe rejection episodes	up to 58 weeks