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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332201
First Posted: April 11, 2011
Last Update Posted: June 16, 2015
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
April 7, 2011
April 11, 2011
June 16, 2015
July 2011
November 2013   (Final data collection date for primary outcome measure)
determine steady state systemic exposure (AUC 0-24h) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
Same as current
Complete list of historical versions of study NCT01332201 on ClinicalTrials.gov Archive Site
  • determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  • determine tmax (time to attain Cmax) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  • determine C24 (concentration prior to next morning dose) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ]
  • describe rejection episodes [ Time Frame: up to 58 weeks ]
  • describe subject survival [ Time Frame: up to 58 weeks ]
  • describe graft survival [ Time Frame: up to 58 weeks ]
Same as current
Not Provided
Not Provided
 
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Heart Transplantation
  • Lung Transplantation
  • Pancreas (Including SPK) Transplantation
  • Drug: Advagraf
    oral
    Other Names:
    • FK506E
    • MR4
    • tacrolimus modified release
  • Drug: Prograf
    oral
    Other Names:
    • tacrolimus
    • FK506
  • Experimental: Advagraf
    Intervention: Drug: Advagraf
  • Active Comparator: Prograf
    Intervention: Drug: Prograf
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2013
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Italy,   Taiwan,   United Kingdom
 
 
NCT01332201
PMR-EC-1501
2010-019859-21 ( EudraCT Number )
Yes
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
Astellas Pharma Inc
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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