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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by Laboratório Químico Farmacêutico Bergamo Ltda..
Recruitment status was:  Not yet recruiting
Azidus Brasil
Information provided by:
Laboratório Químico Farmacêutico Bergamo Ltda. Identifier:
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Chronic Renal Failure
Biological: heparin sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Resource links provided by NLM:

Further study details as provided by Laboratório Químico Farmacêutico Bergamo Ltda.:

Primary Outcome Measures:
  • Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis [ Time Frame: 4 weeks (12 consecutive sessions) ]

Secondary Outcome Measures:
  • Pharmacodynamic activity of heparin observed through aPTT marker [ Time Frame: 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) ]

Estimated Enrollment: 132
Study Start Date: October 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Actparin® - Laboratorio Bergamo Biological: heparin sodium
5000 UI/mL
Active Comparator: Heparin sodium - APP Pharmaceuticals Biological: heparin sodium
5000 UI/mL


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01346215

Contact: Marcelo A. C. Orlandi , Dr.

Instituto de Nefrologia de Campinas Not yet recruiting
Campinas, São Paulo, Brazil
Contact: Marcelo Orlandi         
Sponsors and Collaborators
Laboratório Químico Farmacêutico Bergamo Ltda.
Azidus Brasil
Principal Investigator: Marcelo A. C. Orlandi, Dr. Instituto de Nefrologia de Campinas
  More Information

Additional Information:
Responsible Party: Marcelo A. C. Orlandi, Instituto de Nefrologia de Campinas Identifier: NCT01346215     History of Changes
Other Study ID Numbers: HEPBER0211
Study First Received: April 28, 2011
Last Updated: April 29, 2011

Keywords provided by Laboratório Químico Farmacêutico Bergamo Ltda.:
renal insufficiency, chronic
extracorporeal dialysis
fibrinolytic agents

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017