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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

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ClinicalTrials.gov Identifier: NCT01346215
Recruitment Status : Unknown
Verified April 2011 by Laboratório Químico Farmacêutico Bergamo Ltda..
Recruitment status was:  Not yet recruiting
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Sponsor:
Collaborator:
Azidus Brasil
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Biological: heparin sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346215


Contacts
Contact: Marcelo A. C. Orlandi , Dr.

Locations
Brazil
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
Investigators
Principal Investigator: Marcelo A. C. Orlandi, Dr. Instituto de Nefrologia de Campinas

Additional Information:
Responsible Party: Marcelo A. C. Orlandi, Instituto de Nefrologia de Campinas
ClinicalTrials.gov Identifier: NCT01346215     History of Changes
Other Study ID Numbers: HEPBER0211
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: May 2, 2011
Last Verified: April 2011

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action