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

NCT00828776 | Completed Phase 2

• 1 other identifier: HEPCRI0907
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Keywords

TTPa; Anti-Xa; Adverse Reactions

Outcome Measures

Primary Outcomes (1)

• TTPA Anti-Xa Adverse Reactions

  12 consecutive sessions of hemodialysis

Study Arms (2)

1

EXPERIMENTAL

Heparin Cristália

Biological: Heparin sodic - Cristália

2

ACTIVE COMPARATOR

Heparin - Roche

Biological: heparin - Liquemine (Roche)

Interventions

Heparin sodic - Cristália BIOLOGICAL

5000UI/mL

1

heparin - Liquemine (Roche) BIOLOGICAL

5000UI/mL

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

Lal Clinica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 26, 2009

Record last verified: 2009-01

Locations

BR (1)