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

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.

First Received: January 23, 2009 No Changes Posted

Sponsored by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:	NCT00828776

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 II Phase III

MedlinePlus related topics: Blood Thinners Kidney Failure

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
1: Experimental Heparin Cristália	Biological: Heparin sodic - Cristália 5000UI/mL
2: Active Comparator 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, Sao Paulo
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:	LAL Clinica ( Alexandre Frederico )
Study ID Numbers:	HEPCRI0907
Study First Received:	January 23, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828776 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

TTPa
Anti-Xa
Adverse Reactions

Study placed in the following topic categories:

Renal Insufficiency
Anticoagulants
Heparin, Low-Molecular-Weight
Kidney Failure, Chronic
Fibrinolytic Agents
Cardiovascular Agents
Calcium heparin

Calcium, Dietary
Fibrin Modulating Agents
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Heparin
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Kidney Failure, Chronic
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

Calcium heparin
Fibrin Modulating Agents
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Heparin
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009