Prograf-Advagraf Cross Over Conversion Study

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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 kidney-pancreas transplants. MPA pharmacokinetics will also be evaluated. The results of this study have the potential to change current practice.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• episode of acute rejection within 6 months of screening