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

Last updated: January 23, 2009
Sponsor: Azidus Brasil
Overall Status: Completed

Phase

2/3

Condition

Kidney Disease

Kidney Failure (Pediatric)

Nephropathy

Treatment

N/A

Clinical Study ID

NCT00828776
HEPCRI0907
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 coagulationaggravate 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 thevariable 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 oftraining 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 andanticoagulants and other antiplatelet agents, including antagonists of glycoproteinIIb / IIIa.

Study Design

Total Participants: 62
Study Start date:
September 01, 2007
Estimated Completion Date:
March 31, 2008

Connect with a study center

  • Lal Clinica Pesquisa E Desenvolvimento Ltda

    Valinhos, Sao Paulo 13270000
    Brazil

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.