Advagraf/Prograf Conversion Trial (SG#153)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Norman Muirhead, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01410162
First received: June 29, 2011
Last updated: August 31, 2015
Last verified: August 2015
  Purpose
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 Intervention Phase
Renal Transplant
Kidney Pancreas Transplant
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • renal function [ Time Frame: baseline to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bioequivalence of MPA exposure with Advagraf [ Time Frame: Baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations.


Enrollment: 53
Study Start Date: December 2010
Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advagraf Drug: Tacrolimus
tacrolimus extended release capsules vs Prograf
Active Comparator: Prograf Drug: Tacrolimus
tacrolimus extended release capsules vs Prograf

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410162

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

Responsible Party: Norman Muirhead, Professor, Medicine University of Western Ontario, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01410162     History of Changes
Other Study ID Numbers: R-10-647  17393 
Study First Received: June 29, 2011
Last Updated: August 31, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Renal
Kidney/Pancreas
Transplant
conversion
bioequivalence
Mycophenolate Acid

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

ClinicalTrials.gov processed this record on July 24, 2016