NCT01160276

Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* Renal transplantation \>= one year * eGFR (MDRD) \> 30ml/min * hemoglobin \>= 11g/dl * treatment with tacrolimus or cyclosporine * no previous muscular disease * no drugs interfering with P-glycoprotein or CYP3A activity or expression outcomes * colchicine AUC, Cmax, T1/2 * ABCB1C3435T, CYP3A5 and SLCO1B1 genotypes

Conditions

• Renal Replacement Therapies

Interventions

Type	Name	Description
DRUG	cyclosporine+colchicine	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.
DRUG	tacrolimus	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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-07-12
• Last updated: 2013-04-11

Locations

1 site across 1 country: France