Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

NCT00264693 | Completed

• 3 other identifiers: LMWHplus 3Ethikkommission Luzern 542KSL 2006-1H
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Study Arms (8)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Pfizer: collaborator

Study Sites (1)

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (4)

• 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: 10.4414/smw.2009.11284.

  PMID: 19685350 BACKGROUND

• 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 2009 Jan 19.

  PMID: 19175499 RESULT

• 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 17.

  PMID: 19624460 RESULT

• 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.x. Epub 2010 Jan 17. No abstract available.

  PMID: 20088934 RESULT

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pirmin Schmid, MD

  Luzerner Kantonsspital, Hematology

  PRINCIPAL INVESTIGATOR

• Andreas G Fischer, MD

  Luzerner Kantonsspital, Nephrology

  STUDY DIRECTOR

• Walter A Wuillemin, MD, PhD

  Luzerner Kantonsspital, Hematology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2005
• First Posted: December 13, 2005
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 26, 2010

Record last verified: 2009-08

Locations

CH (1)