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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient starting with dalteparin for prophylaxis OR therapy by order of the treating physician (after having evaluated clinical indication and contraindications).
Renal function normal OR impaired with or without dialysis therapy according to open study groups
Age >= 18 years
Written informed consent

Exclusion criteria

Pregnancy / Lactation
Dalteparin or other LMWH already in use for > 1 day, unless just in use during hemodialysis
Anti-Xa level before first application of dalteparin > 0.3 U / ml
Participation in another study
Anuria OR glomerular filtration rate < 10 ml/min without dialysis
Patient on intensive care unit (ICU)
Cardiovascular unstable patient or probable need for a quick stop of anticoagulation (e.g. emergency surgery)
Patient with a disease whose estimated life expectancy is < 28 days

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

Pfizer

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Dec 13, 2005
Registry last updated: Jan 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed