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Clinical Drug Investigation
Published in: Clinical Drug Investigation 12/2014

01-12-2014 | Original Research Article

Single-Dose, Open-Label Study of the Differences in Pharmacokinetics of Colchicine in Subjects with Renal Impairment, Including End-Stage Renal Disease

Authors: Suman Wason, David Mount, Robert Faulkner

Published in: Clinical Drug Investigation | Issue 12/2014

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Abstract

Background and Objective

The effect of renal impairment on colchicine pharmacokinetics in patients with chronic kidney disease (CKD) has not been studied previously. We evaluated the effect of renal impairment on colchicine pharmacokinetics in patients with CKD.

Methods

The pharmacokinetics and safety of a single, oral 0.6-mg dose of colchicine was evaluated in an open-label study in eight healthy subjects with normal renal function; eight subjects each with mild, moderate, or severe renal impairment; and eight subjects with end-stage renal disease (ESRD) who received a single dose prior to receiving, and again following, hemodialysis.

Results

Colchicine exposure was similar for subjects with normal renal function, mild impairment, or ESRD prior to and during hemodialysis (24.7–31.7 ng·h/mL), but was up to twofold higher in subjects with moderate or severe renal impairment (48.9 and 48.0 ng·h/mL, respectively). A very small amount of the colchicine dose (mean of 5.2 %) was recovered in dialysate.

Conclusions

It appears that patients with mild or moderate renal impairment or those actively receiving hemodialysis do not show accumulation of colchicine, whereas those with severe renal impairment show a doubling of exposure. All patients with renal impairment taking colchicine should be closely monitored, especially as many patients taking colchicine often have other comorbidities and may be taking other medications.
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Metadata
Title
Single-Dose, Open-Label Study of the Differences in Pharmacokinetics of Colchicine in Subjects with Renal Impairment, Including End-Stage Renal Disease
Authors
Suman Wason
David Mount
Robert Faulkner
Publication date
01-12-2014
Publisher
Springer International Publishing
Published in
Clinical Drug Investigation / Issue 12/2014
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI
https://doi.org/10.1007/s40261-014-0238-6

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