search
Back to results

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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Heparin sodic - Cristália
heparin - Liquemine (Roche)
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring TTPa, Anti-Xa, Adverse Reactions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lal Clinica Pesquisa E Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Heparin Cristália

Heparin - Roche

Outcomes

Primary Outcome Measures

TTPA Anti-Xa Adverse Reactions

Secondary Outcome Measures

Full Information

First Posted
January 23, 2009
Last Updated
January 23, 2009
Sponsor
Azidus Brasil
search

1. Study Identification

Unique Protocol Identification Number
NCT00828776
Brief Title
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
Acronym
heparin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
TTPa, Anti-Xa, Adverse Reactions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Heparin Cristália
Arm Title
2
Arm Type
Active Comparator
Arm Description
Heparin - Roche
Intervention Type
Biological
Intervention Name(s)
Heparin sodic - Cristália
Intervention Description
5000UI/mL
Intervention Type
Biological
Intervention Name(s)
heparin - Liquemine (Roche)
Intervention Description
5000UI/mL
Primary Outcome Measure Information:
Title
TTPA Anti-Xa Adverse Reactions
Time Frame
12 consecutive sessions of hemodialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lal Clinica Pesquisa E Desenvolvimento Ltda
City
Valinhos
State/Province
Sao Paulo
ZIP/Postal Code
13270000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs