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Sponsored by: |
L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
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Information provided by: | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
ClinicalTrials.gov Identifier: | NCT00673426 |
The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with Chronic Renal Desease.
Condition | Intervention | Phase |
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Kidney Disease |
Biological: Enoxaparin sodic |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety Evaluation of Use Sodic Enoxaparin Produced by the Laboratory Blausiegel When Compared With Product Clexane of Sanofi-Aventis Ltda in Chronic Renal Desease Patients. |
Enrollment: | 60 |
Study Start Date: | January 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental | Biological: Enoxaparin sodic |
Hemodialysis is a filtering and cleaning process of endogenous and exogenous metabolic blood products. The level control of anticoagulants in patients with chronic renal disease is indispensable. Evidence of clotting as TTPa and evidence of activity of anti-factor Xa should be used as a substrate to protect these patients, undergoing dialysis. The Enoxaparin sodium is one that acts as antithrombin-factor Xa inhibitor of acting directly on the inactivation of antithrombin. Thus, small-chain molecules (low molecular weight) as Enoxaparin show fundamentally anti-Xa high end and low end antitrombotic. The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by Laboratory Sanofi-Aventis in 60 patients with Chronic Renal Desease. The study was kind of parallel, randomized, double-blind and systematic sampling. The drugs were administered during 12 consecutive dialysis sessions at a dose of 1 mg / kg. The activity of the drugs was verified by the strength of markers TTPa and anti-Xa and security was seen through adverse reactions and the evaluation function of capillaries.
The study was conducted 60 patients with chronic renal desease to both sexes, above 18 years aged, who were carrying out haemodialysis treatment during 3 times a week and satisfied inclusion criteria. The investigational products were randomly administered to patients in 12 consecutive dialysis sessions, at a dose of 1 mg / kg. The primary endpoint was safety of using the drug evaluated by monitoring events as:
The secondary endpoint was evaluation of non inferiority clinic, observed over the criteria in maintaining the non-coagulation of the extracorporeal circuit during hemodialysis and the pharmacodynamic curve effect of enoxaparin sodium verified by the strength of markers TTPa, anti-Xa and anti-IIa.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | ENOBLA0108 |
Study First Received: | May 5, 2008 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00673426 |
Health Authority: | Brazil: National Health Surveillance Agency |
enoxaparin chronic renal disease Anticoagulant activity of enoxaparin sodic |
Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Kidney Diseases Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |