Kidney Disease Clinical Trial
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.
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.
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:
- Loss of blood clotting by the system
- Blood coagulation and loss of capillary vein.
- Thrombus of capillary in 3 sessions of monitoring.
- Increase in the patient's hematocrit
- Thrombocytopenia
- Hematoma
- Fever
- Allergic reactions
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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