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Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease (CKD) Patients

2014-08-27 03:19:03 | BioPortfolio

Summary

The purpose of the study is to explore the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

Description

The purpose of the study is to explore the safety and Immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV™, in patients 18 to 75 years of age who have progressive loss of kidney function.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Chronic Kidney Disease

Intervention

HEPLISAV, Engerix

Location

Clinical Research Associates of Tidewater
Norfolk
Virginia
United States

Status

Recruiting

Source

Dynavax Technologies Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:03-0400

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Medical and Biotech [MESH] Definitions

Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.

Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

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