Safety Evaluation of Use Sodic Enoxaparin - Full Text View

Sponsored by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:	NCT00673426

Purpose

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
Kidney Disease	Biological: Enoxaparin sodic	Phase III

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

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.

Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

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
A: Experimental	Biological: Enoxaparin sodic

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673426

Locations

Brazil
Clinica TOP Nefrologia e Diálise
Americana, Brazil

Sponsors and Collaborators

L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

More Information

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

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

enoxaparin
chronic renal disease
Anticoagulant activity of enoxaparin sodic

Study placed in the following topic categories:

Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009