Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

January 25, 2010 updated by: Luzerner Kantonsspital

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Luzern, LU, Switzerland, 6000
        • Kantonsspital Luzern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 11, 2005

First Submitted That Met QC Criteria

December 11, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMWHplus 3
  • Ethikkommission Luzern 542
  • KSL 2006-1H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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