Status:
COMPLETED
Prograf-Advagraf Cross Over Conversion Study
Lead Sponsor:
University Health Network, Toronto
Conditions:
Kidney-Pancreas Transplantation
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on renal function, trough tacrolimus levels, drug-related adverse effects and adherence in stable recipients of...
Detailed Description
Tacrolimus (Prograf ©) has become part of the standard of care for patients receiving solid organ transplants and is part of the immunosuppressive protocol used by kidney-pancreas transplant recipient...
Eligibility Criteria
Inclusion
- recipient of kidney and pancreas transplant
- aged 18 years or older
- 12 months or more since time of transplant
- stable allograft function (creatinine \< 180 µmol/l and eGFR \> 40 ml/min)
- targeted to a tacrolimus trough level of 5-10 ug/ml that has been stable during the prior 3 mo.
Exclusion
- episode of acute rejection within 6 months of screening
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01797341
Start Date
June 1 2013
End Date
February 1 2014
Last Update
September 18 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2