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

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00828776
First received: January 23, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Renal Failure
 Biological: Heparin sodic - Cristália
Biological: heparin - Liquemine (Roche)
 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: 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

Resource links provided by NLM:

Drug Information available for: Heparin
U.S. FDA Resources

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

Primary Outcome Measures:
  • TTPA Anti-Xa Adverse Reactions [ Time Frame: 12 consecutive sessions of hemodialysis ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heparin Cristália
 Biological: Heparin sodic - Cristália
5000UI/mL
Active Comparator: 2
Heparin - Roche
 Biological: heparin - Liquemine (Roche)
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828776

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00828776     History of Changes
Other Study ID Numbers: HEPCRI0907
Study First Received: January 23, 2009
Last Updated: January 23, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
TTPa
Anti-Xa
Adverse Reactions

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
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 May 19, 2013