Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

Renal Insufficiency Clinical Trial

Official title:

Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264693
• Other study ID #: LMWHplus 3
• Secondary ID: Ethikkommission
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2005
• Last updated: January 25, 2010
• Start date: January 2006
• Est. completion date: May 2008

Study information

• Verified date: August 2009
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Insufficiency

Locations

Country	Name	City	State
Switzerland	Kantonsspital Luzern	Luzern	LU

Sponsors (2)

Lead Sponsor	Collaborator
Luzerner Kantonsspital	Pfizer

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Prospective observational cohort study of bioaccumulation of dalteparin at a prophylactic dose in patients with peritoneal dialysis. J Thromb Haemost. 2010 Apr;8(4):850-2. doi: 10.1111/j.1538-7836.2010.03749 — View Citation

Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Apr;7(4):552-8. doi: 10.1111/j.1538-7836.2009.03292.x. Epub 2 — View Citation

Schmid P, Brodmann D, Odermatt Y, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency. J Thromb Haemost. 2009 Oct;7(10):1629-32. doi: 10.1111/j.1538-7836.2009.03556.x. Epub 2009 Jul 1 — View Citation

Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: smw-11284. Review. — View Citation

External Links

•   Luzerner Kantonsspital, Hematology
•   Luzerner Kantonsspital, Nephrology
•   Pirmin Schmid