Safety Evaluation of Use Sodic Enoxaparin

Kidney Disease Clinical Trial

— Enoxaparin  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673426
• Other study ID #: ENOBLA0108
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2008
• Last updated: May 6, 2008
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: January 2008
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults of both sexes, regardless of colour or social class;

• Above 18 years age, with good clinical features, to medical criterion;

• Patients who agreed to participate and signed the Informed Consent;

• Patients with Chronic Kidney Disease in hemodialysis treatment (3 times per week);

• Patients with clearance of creatinine <30ml/min;

• Patients with details of anticoagulants during hemodialysis.

Exclusion Criteria:

• Not agree to the terms described in Informed Consent;

• Volunteers bearers of the sensitivity enoxaparin sodium;

• Volunteers Patients with hypersensitivity to benzyl alcohol;

• Volunteers with a history of bleeding or disease that change of blood clotting could aggravate or terminate the clinical picture, such as tables of gastric ulcer;

• Volunteers with a history of peptic ulcer;

• Patients with body mass index greater than 30;

• Patients with cancer because of the possibility of compromising the function of the variable clotting;

• Patients in a period of post-pregnancy or childbirth;

• Patients with genetic abnormality of the system of coagulation;

• Polytraumatized patients;

• Patients in use of glucocorticoids for at least 1 month;

• Patients in use of other anticoagulants;

• Patients with high rate of bleeding;

• Patients undergo any surgery performed less than 15 days due to the risk of the formation of bruising at the site of surgery.

• Hypertension above 140/90 mmHg

• Patients in use of medicines could affect the hemostasis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

Biological:
• Enoxaparin sodic

Locations

Country	Name	City	State
Brazil	Clinica TOP Nefrologia e Diálise	Americana

Sponsors (1)

Lead Sponsor	Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil,