Advagraf/Prograf Conversion Trial (SG#153)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Lawson Health Research Institute
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 7, 2013
Last verified: August 2013
  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.


Estimated Enrollment: 95
Study Start Date: December 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: June 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
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

Contacts
Contact: Norman Muirhead, MD 519-685-8500 ext 33350 norman.muirhead@lhsc.on.ca
Contact: Patrick Luke, MD 519-685-8500 ext 33180 patrick.luke@lhsc.on.ca

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

No publications provided

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 7, 2013
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
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014