Status:
COMPLETED
Efficacy of Achieving Early Target Trough Levels of Tacrolimus Using CYP3A5 Guided Dosing Versus Weight-based Dosing in a Multi-ethnic Population of Kidney Transplant Recipients in Singapore
Lead Sponsor:
Singapore General Hospital
Conditions:
Kidney Transplant Rejection
Kidney Transplant; Complications
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The investigators hypothesise that the adaptation of CYP3A5 genotype-based Tacrolimus (FK) dosing will lead to earlier FK target achievement and consequently, better clinical outcome after kidney tran...
Detailed Description
Tacrolimus (FK) remains the cornerstone of maintenance immunosuppressants after renal transplantation. However, it is characterised by narrow therapeutic index and large inter-individual variability i...
Eligibility Criteria
Inclusion
- On follow up at SGH between the ages of 21 and 75 years old who had received or are scheduled to receive a living donor renal transplant between January 2016 to January 2023
- Has to receive tacrolimus (FK) (Prograf®; Astellas Pharma, Singapore), mycophenolic acid (MPA) (Cellcept®; Roche, Basel, Switzerland or Myfortic®; Novartis Pharma AG, Basel, Switzerland) and prednisolone as triple immunosuppressive drug maintenance regimen
Exclusion
- Planned to be initiated on non-standard doses of tacrolimus (e.g. planned to initiate on sub-therapeutic doses of tacrolimus)
- Evidence of active liver disease or gastrointestinal disorder that might interfere with the ability to absorb oral medication
- Contraindications to tacrolimus (FK) - e.g. hypersensitivity
- Takes concurrent medications which are known to severely interact with FK (e.g. verapamil, azoles, rifampicin, erythromycin or clarithromycin
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04825262
Start Date
February 1 2021
End Date
April 9 2024
Last Update
November 13 2024
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 767972