Clinical trial NCT00828776: Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Renal Failure
Keywords: TTPa
Anti-Xa
Adverse Reactions
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TTPA Anti-Xa Adverse Reactions
timeFrame: 12 consecutive sessions of hemodialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Lal Clinica Pesquisa E Desenvolvimento Ltda
state: Sao Paulo
Study officials:
References: