Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.

Inclusion Criteria:

• Patients research that agree to participate in the study and sign the informed consent form;
• Patients aged over 18 years, both sexes, regardless of color or social class;
• Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
• Patients with laboratory results within specified acceptance criteria.

Exclusion Criteria:

• Patients who are taking part or took part in another clinical investigational study within 12 months;
• Hypersensitivity to heparin sodium and/or benzyl alcohol;
• History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
• History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
• Severe liver disease;
• Patients in cancer treatment;
• Pregnant and lactating women;
• Use of glucocorticoids over physiological dose;
• Use of other anticoagulants;
• Patients undergoing any surgery performed less than 15 days;
• History of non response or exacerbated response to heparin sodium;
• Patients who do not adapt to 150 UI/kg dose.