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Clinical trial in assigning of tacrolimus dosage regimen according to CYP3A5 genotype in kidney transplant recipients

Clinical trial in assigning of tacrolimus dosage regimen according to CYP3A5 genotype in kidney transplant recipients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20131019001
Enrollment
140
Registered
2013-10-19
Start date
2013-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplatation patients

Interventions

The patients will randomly assigned to receive tacrolimus at genotype guided dosage group ,The patients will randomly assigned to receive tacrolimus at conventional group (fix doses)
Experimental Drug,Experimental Drug
CYP3A5 genotype guided for Tacrolimus doses,Conventional

Sponsors

The National Science and Technology Development Agency
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Khon Kaen University&#44
Collaborator
Khon Kaen
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Kidney transplantation recipients who 1. Age > 18 year old 2. Will have kidney transplantation at Srinagarind hospital&#44; Faculty of Medicine&#44; Khon Kaen University&#44; Khon Kaen&#44; 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&#44; 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

Exclusion criteria: Kidney transplantation recipients who 1. Refuse to join this study 2. Have drug allergy to tacrolimus 3. Have Pregnancy and lactating

Design outcomes

Primary

MeasureTime frame
Tacrolimus blood level (ng/ml)

Secondary

MeasureTime frame
GFR serum Cr and urine 24 hour for Cr (ml/min)

Contacts

Public ContactSirirat Reungjui

Unaffiliated

sirirt_a@kku.ac.th66-43-363664

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026