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

Phase 3

• Conditions: Chronic Renal Failure
• Interventions: Biological: heparin sodium

• Registration Number: NCT01346215
• Lead Sponsor: Laboratório Químico Farmacêutico Bergamo Ltda.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-29
• Last Update Submitted: 2011-04-29
• Study First Posted: 2011-05-02
• Last Update Posted: 2011-05-02
• Study Start: 2011-10
• Primary Completion: 2011-12
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actparin® - Laboratorio Bergamo	heparin sodium	-
Heparin sodium - APP Pharmaceuticals	heparin sodium	-

Primary Outcome Measures

Name	Time	Method
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis	4 weeks (12 consecutive sessions)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic activity of heparin observed through aPTT marker	4 weeks (sessions 1, 6 and 12)
Safety in use of heparin by monitoring adverse events	5 weeks (12 consecutive sessions + 1 post treatment session)

Trial Locations

Locations (1)

Instituto de Nefrologia de Campinas; 🇧🇷 Campinas, São Paulo, Brazil