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

October 26, 2010 updated by: Azidus Brasil

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Valinhos, SP, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 consecutive sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 consecutive sessions.
Evaluation of Anti-Xa
Time Frame: 12 consecutive sessions (4 weeks - 3times/week)
12 consecutive sessions (4 weeks - 3times/week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2010

Last Update Submitted That Met QC Criteria

October 26, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPHIP0509
  • Version 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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