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

Chronic Renal Failure Clinical Trial

— heparin  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828776
• Other study ID #: HEPCRI0907
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 23, 2009
• Last updated: January 23, 2009
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2009
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• Heparin sodic - Cristália
5000UI/mL
• heparin - Liquemine (Roche)
5000UI/mL

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TTPA Anti-Xa Adverse Reactions		12 consecutive sessions of hemodialysis	Yes