Pharmacokinetic analysis was conducted by nonlinear mixed-effects modeling using NONMEM version 7.2 (FOCE + I; ICON Development Solutions, Ellicott City, MD, USA) and PsN version 4.6.0. Pirana software was used as an interface between NONMEM, R (version 3.2.2) and Xpose (version 4). Base model and covariate model development was conducted as described previously [17 (link)]. The following demographic, clinical, and genetic characteristics were evaluated as potential covariates: weight, height, sex, age, ethnicity, co-medication (glucocorticoids and calcium channel blockers), glucocorticoid dose, CYP3A4 and CYP3A5 genotype, primary kidney disease, number of transplantations, renal replacement therapy prior to transplantation (pre-emptive, peritoneal dialysis, or hemodialysis), donor status (living or deceased), human leukocyte antigen mismatches, time post-transplant, hematocrit, creatinine, estimated glomerular filtration rate (Schwartz formula [28 (link)]), aspartate aminotransferase, albumin, C-reactive protein, and total protein.
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Pharmacokinetic Modeling of Transplant Drugs
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Albumin
Aspartate aminotransferase
C reactive protein
Calcium channel blockers
Creatinine
Cyp3a4
Cyp3a5
Donor
Ethnicity
Genetic
Genotype
Glomerular filtration rate
Glucocorticoid
Hematocrit
Hemodialysis
Human leukocyte antigen
Kidney disease
Medication
Peritoneal dialysis
Protein
Renal replacement therapy
Transplant
Transplantation
Corresponding Organization : Erasmus MC
Other organizations : Radboud University Medical Center, Radboud University Nijmegen, Erasmus MC - Sophia Children’s Hospital
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Variable analysis
independent variables
- Weight
- Height
- Ethnicity
- Co-medication (glucocorticoids and calcium channel blockers)
- Glucocorticoid dose
- CYP3A4 and CYP3A5 genotype
- Primary kidney disease
- Number of transplantations
- Renal replacement therapy prior to transplantation (pre-emptive, peritoneal dialysis, or hemodialysis)
- Donor status (living or deceased)
- Human leukocyte antigen mismatches
- Time post-transplant
- Hematocrit
- Creatinine
- Estimated glomerular filtration rate (Schwartz formula)
- Aspartate aminotransferase
- Albumin
- C-reactive protein
- Total protein
- Not explicitly mentioned
- Not explicitly mentioned
- No positive or negative controls specified
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