Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure (heparin)

January 23, 2009 updated by: Azidus Brasil

Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure

The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2
  • 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
    • Sao Paulo
      • Valinhos, Sao Paulo, 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:

  • Adults of both sexes, regardless of color or social class
  • Age over 18 years with a good clinical medical criteria
  • Patients who agreed to participate and signed the Informed Consent
  • Insufficient patients in chronic renal dialysis schedule (3 times per week)
  • Patients with creatinine clearance <30ml/min
  • Patients with indication for anticoagulation during hemodialysis

Exclusion Criteria:

  • Patients with sensitivity to heparin sodium;
  • Patients with hypersensitivity to benzyl alcohol
  • Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
  • Patients with a history of peptic ulcer
  • Patients with body mass index greater than 30
  • Cancer patients because of the possibility of compromising the function of the variable coagulation
  • Patients in period of pregnancy or after delivery
  • Patients with genetic abnormality of the clotting system
  • Polytraumatized patients
  • Patients using glucocorticoids for at least 1 month
  • Patients using other anticoagulants
  • Patients with high rate of bleeding
  • Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
  • Hypertension above 140/90 mmHg
  • Patients using medications that could affect hemostasis
  • Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Heparin Cristália
Biological: Heparin sodic - Cristália
5000UI/mL
Active Comparator: 2
Heparin - Roche
Biological: heparin - Liquemine (Roche)
5000UI/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TTPA Anti-Xa Adverse Reactions
Time Frame: 12 consecutive sessions of hemodialysis
12 consecutive sessions of hemodialysis

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

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (Estimate)

January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2009

Last Update Submitted That Met QC Criteria

January 23, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPCRI0907

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.

Clinical Trials on Chronic Renal Failure

Clinical Trials on Heparin sodic - Cristália

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe