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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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Chronic Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Actparin® - Laboratorio Bergamo

Group Type EXPERIMENTAL

heparin sodium

Intervention Type BIOLOGICAL

5000 UI/mL

Heparin sodium - APP Pharmaceuticals

Group Type ACTIVE_COMPARATOR

heparin sodium

Intervention Type BIOLOGICAL

5000 UI/mL

Interventions

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heparin sodium

5000 UI/mL

Intervention Type BIOLOGICAL

heparin sodium

5000 UI/mL

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No