Advagraf/Prograf Conversion Trial (SG#153)

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: NCT01410162
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : September 1, 2015
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Norman Muirhead, Lawson Health Research Institute

Brief Summary:
Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.

Condition or disease Intervention/treatment Phase
Renal Transplant Kidney Pancreas Transplant Drug: Tacrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.
Study Start Date : December 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Advagraf Drug: Tacrolimus
tacrolimus extended release capsules vs Prograf
Active Comparator: Prograf Drug: Tacrolimus
tacrolimus extended release capsules vs Prograf

Primary Outcome Measures :
  1. renal function [ Time Frame: baseline to 6 months ]

Secondary Outcome Measures :
  1. Bioequivalence of MPA exposure with Advagraf [ Time Frame: Baseline, 12 weeks and 24 weeks ]
    Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Renal transplant or Renal Pancreas patients who are > 12 months post transplant
  • Stable allograft function defined as eGFR > 30-60ml/min
  • Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months
  • Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent

Exclusion Criteria:

  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
  • Treated rejection within 3 months of randomization.
  • Increased serum creatinine > 20% within 3 months of randomization.
  • Subject is pregnant or breastfeeding
  • Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol

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): NCT01410162

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Norman Muirhead
Astellas Pharma Canada, Inc.
Principal Investigator: Norman Muirhead London Health Sciences Centre Inc

Responsible Party: Norman Muirhead, Professor, Medicine University of Western Ontario, Lawson Health Research Institute Identifier: NCT01410162     History of Changes
Other Study ID Numbers: R-10-647
17393 ( Other Identifier: REB )
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Norman Muirhead, Lawson Health Research Institute:
Mycophenolate Acid

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