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Advagraf/Prograf Conversion Trial (SG#153)

This study is currently recruiting participants.
Verified August 2011 by Lawson Health Research Institute
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01410162
First received: June 29, 2011
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

Renal 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
 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:

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

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.


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant patients who are > 12 months post transplant
  • Stable allograft function defined as eGFR > 30-60ml/min
  • Patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months
  • Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-100mg 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410162

Contacts
Contact: Norman Muirhead, MD 519-685-8500 ext 33350 norman.muirhead@lhsc.on.ca

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

No publications provided

Responsible Party: Dr. Norman Muirhead, London Health Sciences Centre Research Inc.
ClinicalTrials.gov Identifier: NCT01410162     History of Changes
Other Study ID Numbers: R-10-647, 17393
Study First Received: June 29, 2011
Last Updated: August 3, 2011
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013