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Report for Clinical Trial NCT01160276

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open Non Randomized Comparative Study Exploring Drug Interaction Between Colchicine and Calcineurin Inhibitors in 2 Groups (Ciclosporin Group and Tacrolimus Group) of Renal Graft Recipients

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


1 C1236T

ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T --- --- G2677T --- --- C1236T ---


2 C3435T

ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T ---


3 G2677T

ABCB1 Haplotypes composed of 3 SNPs: C3435T, G2677T / A and C1236T.. null. --- C3435T --- --- G2677T ---



HPO Nodes