Study to compare a tacrolimus Hexal® based regimen versus a Prograf® based regimen in renal transplantation

Registry ID
EUCTR2011-003795-36
Source registry
EUCTR
Status
Prematurely Ended
Phase
PHASE4
Sponsor
Novartis Pharma GmbH
Start date
2011-12-27
Completion date
2015-08-20
Last update
2026-08-16

Conditions

Summary

PHASE I: To demonstrate that the pharmacokinetics of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over a one month period post-transplantation is comparable to Prograf® in renal transplant patients. PHASE II (including the patients enrolled in Phase I, Phase II study will not be conducted): To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) between both treatment arms at month 6 post-transplantation in renal transplant patients.

Locations

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