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

NCT ID: NCT00828776

Last Updated: 2009-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Heparin Cristália

Group Type: EXPERIMENTAL

Heparin sodic - Cristália

Intervention Type: BIOLOGICAL

5000UI/mL

2

Heparin - Roche

Group Type: ACTIVE_COMPARATOR

heparin - Liquemine (Roche)

Intervention Type: BIOLOGICAL

5000UI/mL

Interventions

Heparin sodic - Cristália

5000UI/mL

Intervention Type: BIOLOGICAL

heparin - Liquemine (Roche)

5000UI/mL

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

LAL Clinica

Locations

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HEPCRI0907

Identifier Type: -

Identifier Source: org_study_id