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

Pharmacodynamics Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01034488
• Other study ID #: HEPEUR1009
• Secondary ID: Version 01
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: December 16, 2009
• Last updated: January 27, 2011
• Start date: August 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2011
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pharmacodynamics

Intervention

Biological:
• Suine
5000UI /mL
• Suine
5000UI/mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Effectiveness in maintaining the absence clotting during hemodialysis.		12 consecutive sessions	No
Secondary	Safety in use of the drug by monitoring events complicating the use of heparin		12 consecutive sessions	Yes