Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
HEPHIP0509
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.
2 other identifiers
interventional
120
1 country
1
Brief Summary
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedOctober 27, 2010
December 1, 2009
11 months
June 4, 2009
October 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of heparin in thrombi formation.
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.
12 consecutive sessions
Secondary Outcomes (2)
Alteration of the pharmacodynamic parameters.
12 consecutive sessions.
Evaluation of Anti-Xa
12 consecutive sessions (4 weeks - 3times/week)
Study Arms (2)
Test
EXPERIMENTALHeparin - Hipolabor
Ative comparator
ACTIVE COMPARATORHeparin - APP
Interventions
Eligibility Criteria
You may qualify if:
- Research that patients agreed to participate and signed the written informed consent;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system.
You may not qualify if:
- Hypersensitivity to heparin sodium and / or benzyl alcohol;
- History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer;
- Severe liver disease;
- Cancer;
- Period of gestation;
- Genetic abnormality of the coagulation system;
- Multiple trauma;
- Use of aspirin in high doses (above 200mg per day);
- Use of glucocorticoids for at least 1 month;
- Use of other anticoagulants;
- Submission of a big surgery done less than 15 days;
- History of persistent hypertension at the end of dialysis than 150/100 mmHg;
- Indicated doses of heparin 20% above or below 150UI/kg.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 5, 2009
Study Start
April 1, 2010
Primary Completion
March 1, 2011
Last Updated
October 27, 2010
Record last verified: 2009-12