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

Sponsor

Azidus Brasil (Industry)

Overall Status

Completed

CT.gov ID

NCT00828776

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2007

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Heparin Cristália	Biological: Heparin sodic - Cristália 5000UI/mL
Active Comparator: 2 Heparin - Roche	Biological: heparin - Liquemine (Roche) 5000UI/mL

Arm

Intervention/Treatment

Experimental: 1

Heparin Cristália

Biological: Heparin sodic - Cristália

5000UI/mL

Active Comparator: 2

Heparin - Roche

Biological: heparin - Liquemine (Roche)

5000UI/mL

Outcome Measures

Primary Outcome Measures

TTPA Anti-Xa Adverse Reactions [12 consecutive sessions of hemodialysis]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.