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Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

NCT00264693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2010-01-26

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Luzerner Kantonsspital

    lead OTHER

Principal Investigators

  • Pirmin Schmid, MD · Luzerner Kantonsspital, Hematology

  • Andreas G Fischer, MD · Luzerner Kantonsspital, Nephrology

  • Walter A Wuillemin, MD, PhD · Luzerner Kantonsspital, Hematology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00264693 on ClinicalTrials.gov