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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01332201
First received: April 7, 2011
Last updated: January 6, 2014
Last verified: January 2014

April 7, 2011
January 6, 2014
June 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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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
Both
18 Years to 65 Years
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
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
Astellas Pharma Inc
January 2014

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