Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

NCT00927602 | Terminated Phase 4 DMC

• 1 other identifier: 2008-005234-79
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.

Conditions

Medical Patients; Renal Insufficiency

Keywords

renal failure; medical patient; venous thromboembolism; prophylaxis; fondaparinux

Outcome Measures

Primary Outcomes (1)

• major bleeding

  up to 48 hours from last injection

Secondary Outcomes (1)

• symptomatic venous thromboembolism

  last treatment dose

Study Arms (1)

fondaparinux

EXPERIMENTAL

Drug: fondaparinux

Interventions

fondaparinux DRUG

once daily sc injection, 1,5 mg, max 14 days

Also known as: Arixtra

fondaparinux

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• Acute medical disease requiring thromboprophylaxis according to international guidelines
• Anticipated immobilization of at least 4 days
• Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
• Written informed consent

You may not qualify if:

• Active bleeding or bleeding in the previous 3 months
• Known bleeding diathesis
• Platelet count \< 100.000
• Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
• Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
• Life expectancy \< 1 month

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University Of Insubria

Varese, 21100, Italy

Location

Related Publications (3)

• Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.

  PMID: 16439370 BACKGROUND

• Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84. doi: 10.7326/0003-4819-144-9-200605020-00011.

  PMID: 16670137 BACKGROUND

• Ageno W, Riva N, Noris P, Di Nisio M, La Regina M, Arioli D, Ria L, Monzani V, Cuppini S, Lupia E, Giorgi Pierfranceschi M, Dentali F; FONDAIR study group. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study. J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.

  PMID: 22925036 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Venous Thromboembolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Walter Ageno, MD

  Università degli Studi dell'Insubria

  STUDY CHAIR

• Francesco Dentali, MD

  Università degli Studi dell'Insubria

  STUDY DIRECTOR

• Alessandro Squizzato, MD

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 24, 2009
• First Posted: June 25, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

IT (1)