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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01332201
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 16, 2015
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: Advagraf Drug: Advagraf
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release

Active Comparator: Prograf Drug: Prograf
Other Names:
  • tacrolimus
  • FK506

Primary Outcome Measures :
  1. determine steady state systemic exposure (AUC 0-24h) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]

Secondary Outcome Measures :
  1. determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  2. determine tmax (time to attain Cmax) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  3. determine C24 (concentration prior to next morning dose) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  4. describe rejection episodes [ Time Frame: up to 58 weeks ]
  5. describe subject survival [ Time Frame: up to 58 weeks ]
  6. describe graft survival [ Time Frame: up to 58 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01332201     History of Changes
Other Study ID Numbers: PMR-EC-1501
2010-019859-21 ( EudraCT Number )
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action