Trial Outcomes & Findings for Pharmacogenetics to Predict Drug Interactions in Kidney Transplant Recipients (NCT NCT01288521)

Last Updated: 2018-03-09

Results Overview

Tac bioavailability alone vs. Tac bioavailability with Keto. To determine F we took the ratio of area under the curve of the oral dose divided by the area under the curve of the IV dose. F was determined by fitting a model that considered the plasma concentration of tac with IV vs. oral dosing.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

baseline and 2 weeks

Results posted on

2018-03-09

Participant Flow

Kidney transplant recipients were recruited from the transplant clinic from 10/2008 to 6/2010.

Assignment to the treatment group was based on CYP3A5 genotype and subjects were eligible only if they had the \*3/\*3 genotype. 22 subjects were consented to participate. Based on genotype, 3 subjects were ineligible to complete the study. Of the 19 eligible subjects, 11 declined to participate. 8 subjects completed the study.

Participant milestones

Participant milestones
Measure	Tacrolimus + Ketoconazole, Then Tacrolimus Alone Randomized, cross over design Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses. Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)	Tacrolimus Alone, Then Tacrolimus + Ketoconazole Randomized, cross over design Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses. Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)
Overall Study STARTED	3	5
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacogenetics to Predict Drug Interactions in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tacrolimus + Ketoconazole, Then Tacrolimus Alone n=3 Participants Randomized, cross over design Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses. Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)	Tacrolimus Alone, Then Tacrolimus + Ketoconazole n=5 Participants Randomized, cross over design Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses. Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Age, Continuous	53 years STANDARD_DEVIATION 12.5 • n=99 Participants	57 years STANDARD_DEVIATION 5.5 • n=107 Participants	55.6 years STANDARD_DEVIATION 8.2 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Region of Enrollment United States	3 participants n=99 Participants	5 participants n=107 Participants	8 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and 2 weeks

Population: Stable kidney transplant recipients

Outcome measures

Outcome measures
Measure	Tacrolimus Alone n=8 Participants cross over design Tacrolimus alone : Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)	Tacrolimus + Ketoconazole n=8 Participants Tacrolimus + Ketoconazole : Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + keotconazole 200 mg every 12 hours x 3 doses.
Tacrolimus Bioavailability (F)	0.224 ratio of oral to IV Standard Deviation 0.107	0.681 ratio of oral to IV Standard Deviation 0.308

Adverse Events

Tacrolimus Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tacrolimus + Ketoconazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sony Tuteja, Pharmd

University of Iowa

Phone: 215-573-7834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place