Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure

NCT01034488 | Unknown Phase 2

• 2 other identifiers: HEPEUR1009Version 01
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis.
2. 2.Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.

Conditions

Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Effect (activity) of heparin observed for markers for aPTT and anti-Xa.

  12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.

Secondary Outcomes (2)

• Effectiveness in maintaining the absence clotting during hemodialysis.

  12 consecutive sessions

• Safety in use of the drug by monitoring events complicating the use of heparin

  12 consecutive sessions

Study Arms (2)

Heparin sodium - APP

ACTIVE COMPARATOR

5000UI / mL

Biological: Suine

Heparin - Eurofarma

EXPERIMENTAL

5000 UI/ mL

Biological: Suine

Interventions

Suine BIOLOGICAL

5000UI /mL

Heparin sodium - APP

Eligibility Criteria

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

You may qualify if:

• Adults of both sexes, regardless of color or social class;
• Age over 18 years, with good clinical doctor's discretion;
• Patients research that agree to participate in the study and sign the informed consent form (attached);
• Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis

You may not qualify if:

• Non compliance with the terms described in the informed consent FICT;
• Patients suffering from sensitivity studies heparin sodium;
• Patients with hypersensitivity to search benzyl alcohol;
• Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
• Patients with a history of research peptic ulcer;
• Patient with cancer research because of the possibility of impairment of variable coagulation function;
• Patients who are research during pregnancy and postpartum;
• Individuals with a genetic abnormality of the coagulation system;
• Trauma patients;
• Patients on glucocorticoid therapy for at least 1 month;
• Patients using other anticoagulants;
• Patients with a high rate of bleeding;
• Patients undergoing any surgery performed less than 15 days due to the risk of bruising at the site of surgery.
• Patients using drugs that affect hemostasis
• Patients using the following drugs: Salicylates systemic aspirin and other NSAIDs, including ketorolac, Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: January 28, 2011

Record last verified: 2011-01