Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure (heparin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828776
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : January 26, 2009
Information provided by:
Azidus Brasil

Brief Summary:
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Biological: Heparin sodic - Cristália Biological: heparin - Liquemine (Roche) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Heparin Cristália
Biological: Heparin sodic - Cristália
Active Comparator: 2
Heparin - Roche
Biological: heparin - Liquemine (Roche)

Primary Outcome Measures :
  1. TTPA Anti-Xa Adverse Reactions [ Time Frame: 12 consecutive sessions of hemodialysis ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 a good clinical medical criteria
  • Patients who agreed to participate and signed the Informed Consent
  • Insufficient patients in chronic renal dialysis schedule (3 times per week)
  • Patients with creatinine clearance <30ml/min
  • Patients with indication for anticoagulation during hemodialysis

Exclusion Criteria:

  • Patients with sensitivity to heparin sodium;
  • Patients with hypersensitivity to benzyl alcohol
  • Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
  • Patients with a history of peptic ulcer
  • Patients with body mass index greater than 30
  • Cancer patients because of the possibility of compromising the function of the variable coagulation
  • Patients in period of pregnancy or after delivery
  • Patients with genetic abnormality of the clotting system
  • Polytraumatized patients
  • Patients using glucocorticoids for at least 1 month
  • Patients using other anticoagulants
  • Patients with high rate of bleeding
  • Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
  • Hypertension above 140/90 mmHg
  • Patients using medications that could affect hemostasis
  • Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828776

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil

Responsible Party: Alexandre Frederico, LAL Clinica Identifier: NCT00828776     History of Changes
Other Study ID Numbers: HEPCRI0907
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: January 26, 2009
Last Verified: January 2009

Keywords provided by Azidus Brasil:
Adverse Reactions

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action