Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function - Full Text View

Sponsor:	Luzerner Kantonsspital
Collaborator:	Pfizer
Information provided by:	Luzerner Kantonsspital
ClinicalTrials.gov Identifier:	NCT00264693

Purpose

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	Phase
Renal Insufficiency	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

Further study details as provided by Luzerner Kantonsspital:

Enrollment:	96
Study Start Date:	January 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264693

Locations

Switzerland
Kantonsspital Luzern
Luzern, LU, Switzerland, 6000

Sponsors and Collaborators

Luzerner Kantonsspital

Pfizer

Investigators

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

More Information

Additional Information:

Luzerner Kantonsspital, Hematology This link exits the ClinicalTrials.gov site

Luzerner Kantonsspital, Nephrology This link exits the ClinicalTrials.gov site

Pirmin Schmid This link exits the ClinicalTrials.gov site

Publications:

Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Jan 19; [Epub ahead of print]

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 Jul 17; [Epub ahead of print]

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 Jan 17; [Epub ahead of print] No abstract available.

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.

Responsible Party:	W.A. Wuillemin, MD PhD, Head, Division of Hematology and Hematology Central Laboratory, Kantonsspital Luzern, Luzern, Switzerland
ClinicalTrials.gov Identifier:	NCT00264693 History of Changes
Other Study ID Numbers:	LMWHplus 3, Ethikkommission Luzern 542, KSL 2006-1H
Study First Received:	December 11, 2005
Last Updated:	January 25, 2010
Health Authority:	Switzerland: Swissmedic

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases
Dalteparin
Anticoagulants
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012