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 because the information has not been verified recently.
Verified April 2011 by Laboratório Químico Farmacêutico Bergamo Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
Laboratório Químico Farmacêutico Bergamo Ltda.
ClinicalTrials.gov Identifier:
NCT01346215
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic activity of heparin observed through aPTT marker [ Time Frame: 4 weeks (sessions 1, 6 and 12) ] [ Designated as safety issue: No ]
  • Safety in use of heparin by monitoring adverse events [ Time Frame: 5 weeks (12 consecutive sessions + 1 post treatment session) ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Principal Investigator: Marcelo A. C. Orlandi, Dr. Instituto de Nefrologia de Campinas
  More Information

Additional Information:
No publications provided

Responsible Party: Marcelo A. C. Orlandi, Instituto de Nefrologia de Campinas
ClinicalTrials.gov Identifier: NCT01346215     History of Changes
Other Study ID Numbers: HEPBER0211
Study First Received: April 28, 2011
Last Updated: April 29, 2011
Health Authority: Brazil: National Health Surveillance Agency

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

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

ClinicalTrials.gov processed this record on October 20, 2014