Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01034488|
Recruitment Status : Unknown
Verified January 2011 by Azidus Brasil.
Recruitment status was: Not yet recruiting
First Posted : December 17, 2009
Last Update Posted : January 28, 2011
Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis.
Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
- Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.
|Condition or disease||Intervention/treatment||Phase|
|Pharmacodynamics||Biological: Suine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||February 2012|
Active Comparator: Heparin sodium - APP
5000UI / mL
Experimental: Heparin - Eurofarma
5000 UI/ mL
- Effect (activity) of heparin observed for markers for aPTT and anti-Xa. [ Time Frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks. ]
- Effectiveness in maintaining the absence clotting during hemodialysis. [ Time Frame: 12 consecutive sessions ]
- Safety in use of the drug by monitoring events complicating the use of heparin [ Time Frame: 12 consecutive sessions ]