Status:
COMPLETED
Advagraf/Prograf Conversion Trial
Lead Sponsor:
Norman Muirhead
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Renal Transplant
Kidney Pancreas Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 funct...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01410162
Start Date
December 1 2010
End Date
December 1 2014
Last Update
September 1 2015
Active Locations (1)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5