Clinical Trial in Assigning of Tacrolimus Dosage Regimen According to CYP3A5 Genotype in Kidney Transplant Recipients

Launched by KHON KAEN UNIVERSITY · Jun 1, 2017

Keywords

ClinConnect Summary

Objective

1. To determine the clinical outcome of tacrolimus treatment in kidney transplant recipients between genotype guided dosage regimen group and conventional group
2. To determine the influence of CYP3A5 polymorphism on clinical outcome of kidney transplantation recipients Review article Kidney transplantation is the most appropriated treatment in end stage renal failure patients in order to improve quality of life. National health security office of Thailand estimates the cost of kidney transplantation around 250,000 to 400,000 baht per patient. However, patients have to take immun...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Kidney transplantation recipients who
• • 1. Age \> 18 year old
• • 2. Will have kidney transplantation at Srinagarind hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
• • 3. Will have the first kidney transplantation
• • 4. Will receive tacrolimus as immunosuppressive to prevent graft rejection
• • 5. Will have AST and ALT \< 2 time of normal level, total bilirubin \<1.5 mg/dl and direct bilirubin within normal limited
• • 6. Welling to volunteer in this study and sign the inform consent
• Exclusion Criteria:
• • Kidney transplantation recipients who
• • 1. Refuse to join this study
• • 2. Have drug allergy to tacrolimus
• • 3. Have Pregnancy and lactating Intervention All renal transplantation waiting list patients will invited to join this study and sign inform consent. The patients who will be enroll to this study, will be drawn the blood for 6 ml to perform CYP3A5 genotype assay.
• • Patients who perform kidney transplantation and enrolled to this study will randomly assign in equal number to receive tacrolimus doses as in table 1 hr before transplantation and after transplantation. Tacrolimus blood level, BUN/Cr, will regularly perform on day 1, 3. 4, 5, 7, 14 and 28 during induction phase (1st-4th week after kidney transplantation). Moreover, urine 24 hour for Cr, protein will perform in day 7, 14, 28 after transplantation. The physicians will modify the daily dose of tacrolimus according to their practice in order to achieve target range of trough concentration (5-8 ng/ml). Patients will receive other immunosuppressive such as corticosteroid, mycophenolate mofetil as general practice.
• • During maintenance phase (5th-24th week after kidney transplantation) tacrolimus doses will be adjusted as in table 1. Tacrolimus blood level, BUN/Cr and urine 24 hour for Cr and protein will be perform on 5, 8, 12, 16, 20, 24 after transplantation. The physicians will modify the daily dose of tacrolimus according to their practice in order to achieve target range of trough concentration (3-5 ng/ml).

Trial Officials