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

NCT03173820 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-06-02

No results posted yet for this study

Summary

Kidney transplantation is the most appropriated treatment in end stage renal failure patients in order to improve quality of life. However, patients have to take immunosuppressive drugs to prevent graft rejection. Tacrolimus is the most common immunosuppressive drug used now. However, tacrolimus has narrow therapeutic level and needs regularly therapeutic monitor because of inter-individual variation in dosage regimen. Not only age, body weight and drug interaction but also genetic factor in metabolic pathway of tacrolimus plays an important role in tacrolimus blood level. Previous data showed CYP3A5 genetic polymorphism was significant effect tacrolimus blood level. From previous study showed the mean dose of tacrolimus required for the induction phase was significantly higher (P= 0.006) in the CYP3A5\*1/\*1 group at 0.142±0.050 mg/kg/day than that required by patients who carried either the CYP3A5\*1/\*3 group of 0.097±0.040 mg/kg/day or the CYP3A5\*3/\*3 group of 0.077±0.020 mg/kg/day. Tacrolimus maintenance dose required for CYP3A5\*1/\*1 group of 0.12±0.03 mg/kg/day was 1.3 times higher (P\<0.0001) than used for the CYP3A5\*1/\*3 at 0.09±0.03 mg/kg/day and 2.4 times higher than the CYP3A5\*3/\*3 group of 0.05±0.02 mg/kg/day. Therefore, the investigators plan to investigate a prospective study to determine the clinical outcome of tacrolimus treatment in kidney transplant recipients between genotype guided dosage regimen group and conventional group.

Conditions

  • Kidney Transplantation

Interventions

GENETIC

Genotype guided

Tacrolimus will be prescribed depend on CYP3A5 genotype. CYP3A5\*1/\*1 patients will receive tacrolimus 0.125 mg/kg/day. CYP3A5\*1/\*3 patients will receive tacrolimus 0.1 mg/kg/day. CYP3A5\*3/\*3 patients will received tacrolimus 0.08 mg/kg/day. Tacrolimus target level for this phase will be 5-8 ng/ml.

GENETIC

Conventional

Tacrolimus will be prescribed 0.1 mg/kg /day for all patients to achieve tacrolimus level 5-8 ng/ml.

Sponsors & Collaborators

  • National Science and Technology Development Agency, Thailand

    collaborator OTHER_GOV

  • Khon Kaen University

    lead OTHER

Principal Investigators

  • Suda Vannaprasaht, MD · Faculty of Medicine, Khon Kaen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-12-31
Completion
2018-06-30
FDA Drug
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173820 on ClinicalTrials.gov