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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Biological: heparin sodium
* Biological: heparin sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actparin® - Laboratorio Bergamo<br> | Biological: heparin sodium<br>* 5000 UI/mL<br>|
| Active Comparator: Heparin sodium - APP Pharmaceuticals<br> | Biological: heparin sodium<br>* 5000 UI/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis |  | 4 weeks (12 consecutive sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, renal insufficiency, chronic, extracorporeal dialysis, fibrinolytic agents, anticoagulants, aPTT