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Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure. (HEPHIP0509)

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 December 2009 by Azidus Brasil.
Recruitment status was:  Active, not recruiting
Information provided by:
Azidus Brasil Identifier:
First received: June 4, 2009
Last updated: October 26, 2010
Last verified: December 2009
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin

Condition Intervention Phase
Biological: heparin sodium - APP
Biological: Heparin sodium - Hipolabor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.

Resource links provided by NLM:

Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Effectiveness of heparin in thrombi formation. [ Time Frame: 12 consecutive sessions ]
    During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.

Secondary Outcome Measures:
  • Alteration of the pharmacodynamic parameters. [ Time Frame: 12 consecutive sessions. ]
    During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.

  • Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Heparin - Hipolabor
Biological: Heparin sodium - Hipolabor
Heparin 5000 IU / mL
Active Comparator: Ative comparator
Heparin - APP
Biological: heparin sodium - APP
Heparin 5000 IU / mL


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

Inclusion Criteria:

  1. Research that patients agreed to participate and signed the written informed consent;
  2. Patients aged over 18 years, both sexes, regardless of color or social class;
  3. 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.

Exclusion Criteria:

  1. Hypersensitivity to heparin sodium and / or benzyl alcohol;
  2. History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
  3. Severe liver disease;
  4. Cancer;
  5. Period of gestation;
  6. Genetic abnormality of the coagulation system;
  7. Multiple trauma;
  8. Use of aspirin in high doses (above 200mg per day);
  9. Use of glucocorticoids for at least 1 month;
  10. Use of other anticoagulants;
  11. Submission of a big surgery done less than 15 days;
  12. History of persistent hypertension at the end of dialysis than 150/100 mmHg;
  13. Indicated doses of heparin 20% above or below 150UI/kg.
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Please refer to this study by its identifier: NCT00914472

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
Azidus Brasil
  More Information

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda Identifier: NCT00914472     History of Changes
Other Study ID Numbers: HEPHIP0509
Version 01
Study First Received: June 4, 2009
Last Updated: October 26, 2010

Keywords provided by Azidus Brasil:
Preventing the thrombi formation

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017