Advagraf/Prograf Conversion Trial
SG#153
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.
2 other identifiers
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 1, 2015
August 1, 2015
3.2 years
June 29, 2011
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
renal function
baseline to 6 months
Secondary Outcomes (1)
Bioequivalence of MPA exposure with Advagraf
Baseline, 12 weeks and 24 weeks
Study Arms (2)
Advagraf
ACTIVE COMPARATORPrograf
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norman Muirheadlead
- Astellas Pharma Canada, Inc.collaborator
Study Sites (1)
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Muirhead
London Health Sciences Centre Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Medicine University of Western Ontario
Study Record Dates
First Submitted
June 29, 2011
First Posted
August 4, 2011
Study Start
December 1, 2010
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
September 1, 2015
Record last verified: 2015-08