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Report for Clinical Trial NCT01160276
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Ciclosporin inhibits P-glycoprotein should increase colchicine bioavailability whereas
tacrolimus should not influence colchicine disposition.
This is a prospective, controlled, open labeled study performed in renal graft recipients
comparing colchicine single dose (1mg) pharmacokinetics in 14 patients treated with
tacrolimus and 14 patients treated with cyclosporin.
NCT01160276 Renal Replacement Therapies
Description: the 14 patients of the 1st group are under cyclosporine and One pill of colchimax 1mg will be taken by all the patients at Day 3.
Group Labels: 1 Cyclosporine
Description: the 14 patients of the second group are under tacrolimus and One pill of colchimax 1mg will be taken by all the patients at Day 3.
Group Labels: 1 Tacrolimus
Primary Outcomes Measure: Area under the curve of plasma concentration of colchicine over time 0-∞ Time: 4 weeks
Secondary Outcomes Measure: Half-life of colchicine (T1/2). Time: 4 weeks
Measure: AUC0-3h colchicine to focus the analysis on the absorption phase (argument in favor of an interaction-dependent P-gp) Time: 4 weeks
Measure: Cmax observed colchicine. Time: 4 weeks
Measure: Residual tacrolimus or cyclosporine concentrations Time: 4 weeks
Measure: ABCB1 genotype at position 3435 (rs 1045642) or 3435 cc, 3435TT, heterozygotes could not be included in the tacrolimus group. Time: 4 weeks
Measure: ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T. Time: 4 weeks
Measure: CYP3A5 Genotype: search for the allele * 1 (rs 776746): 3 possible genotypes CYP3A5 * 3 / * 3 - CYP3A5 * 3 / * 1 - CYP3A5 * 1 / * 1. Time: 4 weeks
Measure: GFR calculated by MDRD formula. Time: 4 weeks
Measure: BMI Time: 4 weeks
Measure: Drug related (azathioprine, mycophenolic acid, diuretics, ACE inhibitors, ARAII) Time: 4 weeks
There are 3 SNPs
ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T --- --- G2677T --- --- C1236T ---