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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00914472
First received: June 4, 2009
Last updated: October 26, 2010
Last verified: December 2009
  Purpose

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
Thrombus
Biological: heparin sodium - APP
Biological: Heparin sodium - Hipolabor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Effectiveness of heparin in thrombi formation. [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00914472

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, SP, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda
ClinicalTrials.gov Identifier: NCT00914472     History of Changes
Other Study ID Numbers: HEPHIP0509, Version 01
Study First Received: June 4, 2009
Last Updated: October 26, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Preventing the thrombi formation

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

ClinicalTrials.gov processed this record on July 10, 2014