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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 7, 2011
Last updated: January 6, 2014
Last verified: January 2014

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.

Condition Intervention Phase
Heart Transplantation
Lung Transplantation
Pancreas (Including SPK) Transplantation
Drug: Advagraf
Drug: Prograf
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • determine steady state systemic exposure (AUC 0-24h) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
  • determine tmax (time to attain Cmax) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
  • determine C24 (concentration prior to next morning dose) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
  • describe rejection episodes [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]
  • describe subject survival [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]
  • describe graft survival [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advagraf Drug: Advagraf
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release
Active Comparator: Prograf Drug: Prograf
Other Names:
  • tacrolimus
  • FK506


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01332201

Vienna, Austria
Leuven, Belgium
Paris, France
Milan, Italy
Padova, Italy
Taipei, Taiwan
United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc Identifier: NCT01332201     History of Changes
Other Study ID Numbers: PMR-EC-1501, 2010-019859-21
Study First Received: April 7, 2011
Last Updated: January 6, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: National Institute of Health
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 15, 2014