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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01034488
First received: December 16, 2009
Last updated: January 27, 2011
Last verified: January 2011
  Purpose
  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.

Condition Intervention Phase
Pharmacodynamics
Biological: Suine
Phase 2
Phase 3

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

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Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Effect (activity) of heparin observed for markers for aPTT and anti-Xa. [ Time Frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness in maintaining the absence clotting during hemodialysis. [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: No ]
  • Safety in use of the drug by monitoring events complicating the use of heparin [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: August 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Heparin sodium - APP
5000UI / mL
Biological: Suine
5000UI /mL
Experimental: Heparin - Eurofarma
5000 UI/ mL
Biological: Suine
5000UI/mL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: LAL Clínica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT01034488     History of Changes
Other Study ID Numbers: HEPEUR1009, Version 01
Study First Received: December 16, 2009
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014