Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure. (HEPHIP0509)
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|ClinicalTrials.gov Identifier: NCT00914472|
Recruitment Status : Unknown
Verified December 2009 by Azidus Brasil.
Recruitment status was: Active, not recruiting
First Posted : June 5, 2009
Last Update Posted : October 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Thrombus||Biological: heparin sodium - APP Biological: Heparin sodium - Hipolabor||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||March 2011|
Heparin - Hipolabor
Biological: Heparin sodium - Hipolabor
Heparin 5000 IU / mL
Active Comparator: Ative comparator
Heparin - APP
Biological: heparin sodium - APP
Heparin 5000 IU / mL
- 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.
- 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.
- Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914472
|Lal Clinica Pesquisa E Desenvolvimento Ltda|
|Valinhos, SP, Brazil, 13270000|