Ignite Creation Date:
2024-05-05 @ 10:41 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01160276
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2010-07-09
Brief Title:
Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
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
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLCHINCAL
Brief 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
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 30mlmin
hemoglobin 11gdl
treatment with tacrolimus or cyclosporine
no previous muscular disease
no drugs interfering with P-glycoprotein or CYP3A activity or expression outcomes
colchicine AUC Cmax T12
ABCB1C3435T CYP3A5 and SLCO1B1 genotypes
eGFR MDRD 30mlmin
hemoglobin 11gdl
treatment with tacrolimus or cyclosporine
no previous muscular disease
no drugs interfering with P-glycoprotein or CYP3A activity or expression outcomes
colchicine AUC Cmax T12
ABCB1C3435T CYP3A5 and SLCO1B1 genotypes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None