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 (COLCHINCAL)

NCT01160276 Phase 1 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1
Status	COMPLETED
Enrolment	17
Start date	2010-05
Completion	2012-01

Conditions

• Renal Replacement Therapies

Interventions

• cyclosporine+colchicine
• tacrolimus

Primary outcomes

• Area under the curve of plasma concentration of colchicine over time 0-∞ — 4 weeks

Countries

France