Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function|
|Study Start Date:||January 2006|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
P - A
Prophylactic Dosage, GFR >= 60 mL/min/1.73m^2
P - B
Prophylactic Dosage, GFR 30-59 mL/min/1.73m^2
P - C
Prophylactic Dosage, GFR < 30 mL/min/1.73m^2
P - CAPD
Prophylactic Dosage, CAPD
T - A
Therapeutic Dosage, GFR >= 60 mL/min/1.73m^2
T - B
Therapeutic Dosage, GFR 30-59 mL/min/1.73m^2
T - C
Therapeutic Dosage, GFR < 30 mL/min/1.73m^2
T - CAPD
Therapeutic Dosage, CAPD
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264693
|Luzern, LU, Switzerland, 6000|
|Principal Investigator:||Pirmin Schmid, MD||Luzerner Kantonsspital, Hematology|
|Study Director:||Andreas G Fischer, MD||Luzerner Kantonsspital, Nephrology|
|Study Chair:||Walter A Wuillemin, MD, PhD||Luzerner Kantonsspital, Hematology|