Skip to main content
OpenTrials
Completed

NCT Number: NCT00828776

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin sodic - Cristália

Biological

5000UI/mL

heparin - Liquemine (Roche)

Biological

5000UI/mL

Primary outcomes

  1. TTPA Anti-Xa Adverse Reactions

    Time frame: 12 consecutive sessions of hemodialysis

Sponsors and collaborators

Lead sponsor

Azidus Brasil

Industry

Registry information

Official study 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

Acronym: heparin

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2009
Registry last updated
Jan 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.