Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00264693
Status:
COMPLETED
Last Update Posted:
2010-01-26
First Post:
2005-12-11
Brief Title:
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Sponsor:
Luzerner Kantonsspital
Organization:
Luzerner Kantonsspital
Study Overview
Official Title:
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Status:
COMPLETED
Status Verified Date:
2009-08
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:
None
Brief Summary:
Low molecular weight heparins LMWH have been shown to be at least as efficient and safe as unfractioned heparin UFH in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists VKA
Due to their pharmacokinetic characteristics LMWH tend to accumulate in patients with impaired renal function Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency
Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function
Due to their pharmacokinetic characteristics LMWH tend to accumulate in patients with impaired renal function Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency
Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KSL 2006-1H | None | None | None |
| Ethikkommission Luzern 542 | None | None | None |