SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT01160276
Developed by Shray Alag, 2019.
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
2 Interventions
Name: cyclosporine+colchicine
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.Type: Drug
Cyclosporine
Name: tacrolimus
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.Type: Drug
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
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There are 3 SNPs
SNPs
ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T --- --- G2677T --- --- C1236T ---
ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T ---
ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T --- --- G2677T ---
HPO Nodes