A Selective Cytopheretic Inhibitory Device to Treat the Immunological Dysregulation of Acute and Chronic Renal Failure

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Abstract

Background: The poor outcomes in patients with acute kidney injury (AKI) and end-stage renal disease (ESRD) on chronic dialysis are due to immune dysregulation associated with these disorders. Evolving evidence suggests that the kidney, and specifically renal epithelial cells, plays an important role in the immunological response of leukocytes under disease states. Method: In this regard, the development of two therapeutic approaches utilizing renal epithelial cells and ‘smart’ immunomodulatory membranes has been tested in preclinical animal models and clinical trials. Results: These two approaches have been demonstrated in phase II human trials to improve the survival of intensive care unit patients with AKI and multiorgan failure. The use of a ‘smart’ immunomodulatory membrane is also being evaluated in a small exploratory clinical trial to assess its effects on immunoregulation in ESRD patients requiring chronic hemodialysis. Conclusions: The use of renal progenitor/stem cell therapy and/or cytopheretic membranes may result in effective treatments to alter the dysregulated immunological state of acute or chronic renal failure and improve the outcomes of these diseases.

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Most cited references 35

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Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

Bengt C Fellström, Alan Jardine, Roland E Schmieder … (2009)

Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P=0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P=0.51). In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.) 2009 Massachusetts Medical Society

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Mortality caused by sepsis in patients with end-stage renal disease compared with the general population.

M. Sarnak, B Jaber (2000)

In the United States, infection is second to cardiovascular disease as the leading cause of death in patients with end-stage renal disease (ESRD), and septicemia accounts for more than 75% of this category. This increased susceptibility to infections is partly due to uremia, old age, and comorbid conditions. Although it is intuitive to believe that mortality caused by sepsis may be higher in patients with ESRD compared with the general population (GP), no such data are currently available. We compared annual mortality rates caused by sepsis in patients with ESRD (U.S. Health Care Financing Administration 2746 death notification form) with those in the GP (death certificate). Data were abstracted from the U.S. Renal Data System (1994 through 1996 Special Data request) and the National Center for Health Statistics. Data were stratified by age, gender, race, and diabetes mellitus (DM). Sensitivity analyses were performed to account for potential limitations of the data sources. Overall, the annual percentage mortality secondary to sepsis was approximately 100- to 300-fold higher in dialysis patients and 20-fold higher in renal transplant recipients (RTRs) compared with the GP. Mortality caused by sepsis was higher among diabetic patients across all populations. After stratification for age, differences between groups decreased but retained their magnitude. These findings remained robust despite a wide range of sensitivity analyses. Indeed, mortality secondary to sepsis remained approximately 50-fold higher in dialysis patients compared with the GP, using multiple cause-of-death analyses; was approximately 50-fold higher in diabetic patients with ESRD compared with diabetic patients in the GP, when accounting for underreporting of DM on death certificates in the GP; and was approximately 30-fold higher in RTRs compared with the GP, when accounting for the incomplete ascertainment of cause of death among RTRs. Furthermore, despite assignment of primary cause-of-death to major organ infections in the GP, annual mortality secondary to sepsis remained 30- to 45-fold higher in the dialysis population. Patients with ESRD treated by dialysis have higher annual mortality rates caused by sepsis compared with the GP, even after stratification for age, race, and DM. Consequently, this patient population should be considered at high-risk for the development of lethal sepsis.

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Diagnosis, epidemiology and outcomes of acute kidney injury.

K. Liu, Sushrut S Waikar, Glenn Chertow (2008)

Acute kidney injury is an increasingly common and potentially catastrophic complication in hospitalized patients. Early observational studies from the 1980s and 1990s established the general epidemiologic features of acute kidney injury: the incidence, prognostic significance, and predisposing medical and surgical conditions. Recent multicenter observational cohorts and administrative databases have enhanced our understanding of the overall disease burden of acute kidney injury and trends in its epidemiology. An increasing number of clinical studies focusing on specific types of acute kidney injury (e.g., in the setting of intravenous contrast, sepsis, and major surgery) have provided further details into this heterogeneous syndrome. Despite our sophisticated understanding of the epidemiology and pathobiology of acute kidney injury, current prevention strategies are inadequate and current treatment options outside of renal replacement therapy are nonexistent. This failure to innovate may be due in part to a diagnostic approach that has stagnated for decades and continues to rely on markers of glomerular filtration (blood urea nitrogen and creatinine) that are neither sensitive nor specific. There has been increasing interest in the identification and validation of novel biomarkers of acute kidney injury that may permit earlier and more accurate diagnosis. This review summarizes the major epidemiologic studies of acute kidney injury and efforts to modernize the approach to its diagnosis.

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Journal ID (publisher-id): BPU

Journal ID (nlm-ta): Blood Purif

Journal ID (doi): 10.1159/issn.0253-5068

Title: Blood Purification

Publisher: S. Karger AG

ISBN: 978-3-8055-9340-3

ISBN: 978-3-8055-9341-0

ISSN (Print): 0253-5068

ISSN (Electronic): 1421-9735

Publication date Subscription-year: 2010

Publication date (Print): January 2010

Publication date (Electronic): 08 January 2010

Volume: 29

Issue: 2

Pages: 183-190

Affiliations

^aDepartment of Internal Medicine, University of Michigan School of Medicine, and ^bNephrion, Inc., Ann Arbor, Mich., USA; ^cDivision of Nephrology, Huashan Hospital, Fudan University, Shanghai, PR China; ^dDepartment of Internal Medicine, Center for Advanced Medical Education by BK21 Project, Inha University School of Medicine, Incheon, Korea

Article

Publisher ID: 245645 Other ID: Blood Purif 2010;29:183–190

DOI: 10.1159/000245645

PubMed ID: 20093825

SO-VID: db251d44-1dda-4a39-ab21-cd3c703f8988

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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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A Selective Cytopheretic Inhibitory Device to Treat the Immunological Dysregulation of Acute and Chronic Renal Failure

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Abstract

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Karger: Nephrology

Most cited references 35

Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.

Mortality caused by sepsis in patients with end-stage renal disease compared with the general population.

Diagnosis, epidemiology and outcomes of acute kidney injury.

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Cited by 16

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