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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00828776

Acronym

heparin

Enrollment

Registered

2009-01-26

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2009-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

TTPa, Anti-Xa, Adverse Reactions

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.

Interventions

BIOLOGICALHeparin sodic - Cristália

5000UI/mL

BIOLOGICALheparin - Liquemine (Roche)

5000UI/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
TTPA Anti-Xa Adverse Reactions	12 consecutive sessions of hemodialysis

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026