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

April 29, 2011 updated by: Laboratório Químico Farmacêutico Bergamo Ltda.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marcelo A. C. Orlandi, Dr.

Study Locations

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil
        • Instituto de Nefrologia de Campinas
        • Contact:
          • Marcelo Orlandi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratório Químico Farmacêutico Bergamo Ltda.

Collaborators

Azidus Brasil

Investigators

  • Principal Investigator: Marcelo A. C. Orlandi, Dr., Instituto de Nefrologia de Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

April 29, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

May 2, 2011

Last Update Submitted That Met QC Criteria

April 29, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPBER0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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