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Report for Clinical Trial NCT03173820

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03173820 Kidney Transplantation

2 Interventions

Name: Genotype guided

Description: 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.
Type: Genetic
Group Labels: 1

Genotype guided

Name: Conventional

Description: Tacrolimus will be prescribed 0.1 mg/kg /day for all patients to achieve tacrolimus level 5-8 ng/ml.
Type: Genetic
Group Labels: 1

Conventional


Primary Outcomes

Description: Proportion of patients whose tacrolimus level were in therapeutic range at day 3 post transplantation

Measure: Mean tacrolimus level

Time: at day 3 after transplantation

Secondary Outcomes

Description: Proportion of patients whose tacrolimus level were in therapeutic range at day 1, 3, 5, 7, 14, 30,60, 90, 120, 150 and 180 days post transplantation

Measure: Mean tacrolimus level

Time: at day 1, 3, 5, 7, 14, 30,60, 90, 120, 150 and 180 days post transplantation

Description: Compare incidence of delay graft rejection between 2 groups

Measure: Incidence of delay graft rejection

Time: day 1- 6 month after transplantation

Description: Compare mean GFR level at day 7, 14, 30, 60, 90, 120, 150, and 180 days after transplantation

Measure: Mean GFR level

Time: at day 7, 14, 30, 60, 90, 120, 150, and 180 days after transplantation

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 A6986G

CYP3A5*3, an A to G transition (A6986G) within intron 3 results in the production of a truncated protein, is the most common allele variant. --- A6986G ---



HPO Nodes