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

Laboratório Químico Farmacêutico Bergamo Ltda.

Status and phase

Unknown

Phase 3

Conditions

Chronic Renal Failure

Treatments

Biological: heparin sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT01346215

HEPBER0211

Details and patient eligibility

About

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.

Enrollment

132 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.