Chronic kidney disease (CKD) is a major global health problem and kidney transplantation remains the most effective renal replacement therapy, providing superior survival and quality of life compared with dialysis. However, long-term graft survival continues to be limited by immune-mediated injury, particularly acute and chronic rejection, necessitating lifelong immunosuppressive therapy. The standard maintenance regimen worldwide and in Thailand comprises a calcineurin inhibitor (CNI), mycoph
Conditions
Interventions
Participants will receive Prograf (tacrolimus, innovator formulation), an oral calcineurin inhibitor widely used as a cornerstone of maintenance immunosuppression in kidney transplant recipients. Prog
Prograf,Salvado,Tacrograf
Sponsors
Thai National Kidney Foundation
Routine to research unit, Faculty of Medicine Siriraj Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Kidney transplant recipients (from living or deceased donors) at Siriraj Hospital, at least 12 months post-transplantation, with regular follow-up. 2. Receiving a stable immunosuppressive regimen consisting of tacrolimus, mycophenolate, and prednisolone, with no dose adjustments within the past month. 3. Age equal or more than 18 years. 4. Willing and able to provide written informed consent. 5. Estimated GFR more than 30 mL/min/1.73 sq.m., calculated using the CKD-EPI equation.
Exclusion criteria
Exclusion criteria: 1. Active or severe infection (bacterial, viral, or fungal). 2. History of biopsy-proven acute rejection within the past 3 months. 3. Currently pregnant or planning pregnancy. 4. Documented poor medication adherence. 5. Combined organ transplantation (e.g., kidney-liver or kidney-pancreas). 6. Recent (within 3 months) change in type or dose of concomitant drugs affecting tacrolimus levels e.g., diltiazem, verapamil, or azole antifungals; patients must have been on a stable regimen for equal and more than 3 months. 7. Concomitant use of other drugs known to affect tacrolimus levels, such as carbamazepine, phenytoin, antiretroviral agents, or anti-TB drugs. 8. Likely need for medications or changes in immunosuppressive regimen that could alter tacrolimus pharmacokinetics during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve of tacrolimus from 0 to 12 hours (AUC) Measured at each pharmacokinetic (PK) phase during steady-state dosing of each formulation (Prograf, Tacrograf, Salvado) AUC0-12 calculated using the trapezoidal rule based on 10 blood sampling for tacrolimus level: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after oral administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax (Maximum concentration) Measured at each pharmacokinetic (PK) phase during steady-state dosing of each formulation (Prograf, Tacrograf, Salvado) Highest measured blood concentration of tacrolimus during the 12-hour sampling period,Tmax (Time to reach maximum concentration) Measured at each pharmacokinetic (PK) phase during steady-state dosing of each formulation (Prograf, Tacrograf, Salvado) Time (hours) from dosing to reach Cmax,Trough level (C0) Measured at each pharmacokinetic (PK) phase during steady-state dosing of each formulation (Prograf, Tacrograf, Salvado) Pre-dose tacrolimus concentration (hour 0),Safety parameters End of study Serum creatinine, liver function tests, complete blood count, and adverse events monitored throughout the study | — |
Countries
Thailand
Contacts
Public ContactGahwin Ruchikajorndech
Faculty of Medicine Siriraj Hospital
Outcome results
None listed