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

Phase 2

Completed

• Conditions: Chronic Renal Failure
• Interventions: Biological: Heparin sodic - Cristália; Biological: heparin - Liquemine (Roche)

• Registration Number: NCT00828776
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-02
• Study Completion: 2008-03
• Status Verified: 2009-01
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Last Update Submitted: 2009-01-23
• Study First Posted: 2009-01-26
• Last Update Posted: 2009-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Heparin sodic - Cristália	Heparin Cristália
2	heparin - Liquemine (Roche)	Heparin - Roche

Primary Outcome Measures

Name	Time	Method
TTPA Anti-Xa Adverse Reactions	12 consecutive sessions of hemodialysis

Trial Locations

Locations (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda; 🇧🇷 Valinhos, Sao Paulo, Brazil