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Report for Clinical Trial NCT01160276
 Developed by Shray Alag, 2020-2021.
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
Group Labels:  1  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
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
 
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 ---