A Phase 4 interventional study of Tacrolimus and Tacrolimus in End Stage Renal Disease, sponsored by University of Oslo School of Pharmacy. Completed at 1 site in Norway. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2014-12-03.
Sponsored by University of Oslo School of Pharmacy · Phase 4, Interventional, and Treatment
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients
12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's enrollment of 28 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Oslo School of Pharmacy is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Drug: Tacrolimus
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
Drug: Tacrolimus
Tested generic
Also known as: Tacrolimus formualted as the generic Tacni
Original formulation used as comparator
Also known as: Tacrolimus formualted as the original Prograf
Bioequivalence
Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.
Time frame: 10 weeks
Population model validation
Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
Time frame: 10 weeks
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oslo School of Pharmacy