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

Sponsor
Azidus Brasil (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01034488
Collaborator
(none)
128
Enrollment
2
Arms
18
Duration (Months)

Study Details

Study Description

Brief 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.

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Biological: Suine
  • Biological: Suine
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2011
Anticipated Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Heparin sodium - APP

5000UI / mL

Biological: Suine
5000UI /mL
Experimental: Heparin - Eurofarma

5000 UI/ mL

Biological: Suine
5000UI/mL

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Effectiveness in maintaining the absence clotting during hemodialysis. [12 consecutive sessions]

  2. Safety in use of the drug by monitoring events complicating the use of heparin [12 consecutive sessions]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azidus Brasil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01034488
Other Study ID Numbers:
  • HEPEUR1009
  • Version 01
First Posted:
Dec 17, 2009
Last Update Posted:
Jan 28, 2011
Last Verified:
Jan 1, 2011

Study Results

No Results Posted as of Jan 28, 2011