Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264693
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : January 26, 2010
Information provided by:
Luzerner Kantonsspital

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.

Condition or disease
Renal Insufficiency

Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
Study Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

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
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
Therapeutic Dosage, CAPD

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of a medical and surcigal department with all levels of renal function who needs Dalteparin for prophylaxis or therapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264693

Kantonsspital Luzern
Luzern, LU, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
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

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: W.A. Wuillemin, MD PhD, Head, Division of Hematology and Hematology Central Laboratory, Kantonsspital Luzern, Luzern, Switzerland Identifier: NCT00264693     History of Changes
Other Study ID Numbers: LMWHplus 3
Ethikkommission Luzern 542
KSL 2006-1H
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action