Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients (NCT02014103) | Clinical Trial Compass
CompletedPhase 4
Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients
United States71 participantsStarted 2015-03
Plain-language summary
The prospective study will compare the relative bioavailability at steady-state pharmacokinetics of 6 tacrolimus formulations in a prospective, 6-way cross-over study including CYP3A5 expressors (n=30) and non-expressor (n=30) transplant patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years or older
✓. Able to participate and willing to give written informed consent/ assent/ consent by parent or legal guardian and to comply with the study visits and restrictions.
✓. Subject who has received a primary or secondary transplant.
✓. Subject who is at least 6 months post-transplant and on a stable dose of tacrolimus as defined by physician, one tacrolimus trough level within the physician defined target range within past 6 months and one additional trough level during the screening period within 30% of the physician defined target range.
✓. BMI less than or equal to 40.
Exclusion criteria
✕. Evidence of any acute rejection
✕. Subjects who require dialysis within 6 months prior to study entry
✕. Recipients of multiple organ transplants
✕. Subjects who have tested positive for HBsAG or HIV, or who are recipients of organ from donors who are known to be HBsAG or HIV positive. Virology screening at the time of transplant.
✕. HepC positive subjects with liver biopsy proven recurrent disease considered relevant by physician oversight.
✕. Subjects with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation
What they're measuring
1
Compare AUC 0-12hr of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Timeframe: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
2
Compare Cmax of Each Tacrolimus Formulation in Expressor and Non Expressor Transplant Recipients
Timeframe: Whole blood samples were collected immediately prior to dosing, at 1, 1.5, 1.75, 2, 2.5, 3 and 4 hours following dosing. Subjects were then instructed to performed fingersticks using dried blood spot cards at 8 and 12 hours post dose.
. History of malignancy, treated or untreated, with the past 2 years with the exception of carcinoma in situ or excised basal cell carcinoma, or hepatocellular carcinoma prior to transplant.
✕. GFR ≤ 35 ml/min measured as estimated using the MDRD4 formula