kidney transplantation AUC,
Conditions
Interventions
CYP3A5 expressers,
diltiazem 60 mg/day,CYP3A5 expressers,
placebo,CYP3A5 non-
expressers,
diltiazem 60 mg/day,CYP3A5 non-
placebo
Experimental Drug,Placebo Comparator Genetic,Experimental Drug,Placebo Comparator Genetic
CYP3A5 expressers with diltiazem administration,CYP3A5 expressers without diltiazem administration,CYP3A5 non-
expressers with diltiazem administration,CYP3A5 non-
expressers without diltiazem administration
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. First kidney transplantation 2. Living related kidney transplant patients 3. Being prescribed mycophenolate mofetil or mycophenate sodium, tacrolimus and prednisolone as maintenance immunosuppressive agent to prevent allograft rejection
Exclusion criteria
Exclusion criteria: 1. more than one organ transplantation 2. ABO incompatible transplantation 3. patients who require anti-thymocyte immunoglobulin for induction therapy 4. patients who receive concomitant drugs (other than methylprednisolone, prednisolone and omeprazole) that may affect CYP3A4 and P-glycoprotein activity 5. patients with history of cirrhosis, elevated liver enzyme more than 3x of upper limit normal (AST>100 U/L and ALT>120 U/L) or hepatitis C viral infection 6. active gastrointestinal disorder 7. anemia (Hb<9 g/dL) 8. hypoalbuminemia (Alb<3 g/dL) 9. blood preesure below 110/70 mmHg 10. fever or active infection 11. incomplete data in medication record and/or computer system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tacrolimus blood concentrations Days 3 and 7, and after 6 months post-transplantation immunoassay | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of mean trough concentration within target tacrolimus trough level Days 3 and 7, and after 6 months post-transplantation immunoassay | — |
Contacts
Public ContactSomratai Vadcharavivad
Chulalongkorn University
Outcome results
None listed