Skip to main content

Main menu

  • Home
  • Content
    • Published Ahead of Print
    • Current Issue
    • Podcasts
    • Subject Collections
    • Archives
    • ASN Meeting Abstracts
    • Saved Searches
  • Authors
    • Submit a Manuscript
    • Author Resources
    • Reprint Information
  • Trainees
    • Peer Review Program
    • Prize Competition
  • About CJASN
    • About CJASN
    • Editorial Team
    • CJASN Impact
    • CJASN Recognitions
  • More
    • Alerts
    • Advertising
    • Reprint Information
    • Subscriptions
    • Feedback
  • ASN Kidney News
  • Other
    • JASN
    • Kidney360
    • Kidney News Online
    • American Society of Nephrology

User menu

  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
American Society of Nephrology
  • Other
    • JASN
    • Kidney360
    • Kidney News Online
    • American Society of Nephrology
  • Subscribe
  • My alerts
  • Log in
  • My Cart
Advertisement
American Society of Nephrology

Advanced Search

  • Home
  • Content
    • Published Ahead of Print
    • Current Issue
    • Podcasts
    • Subject Collections
    • Archives
    • ASN Meeting Abstracts
    • Saved Searches
  • Authors
    • Submit a Manuscript
    • Author Resources
    • Reprint Information
  • Trainees
    • Peer Review Program
    • Prize Competition
  • About CJASN
    • About CJASN
    • Editorial Team
    • CJASN Impact
    • CJASN Recognitions
  • More
    • Alerts
    • Advertising
    • Reprint Information
    • Subscriptions
    • Feedback
  • ASN Kidney News
  • Visit ASN on Facebook
  • Follow CJASN on Twitter
  • CJASN RSS
  • Community Forum
Original ArticlesChronic Kidney Disease
You have accessRestricted Access

Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial

Terumasa Hayashi, Shoichi Maruyama, Masaomi Nangaku, Ichiei Narita, Hideki Hirakata, Kenichiro Tanabe, Satoshi Morita, Yoshiharu Tsubakihara, Enyu Imai, Tadao Akizawa and for the PREDICT Investigators
CJASN May 2020, 15 (5) 608-615; DOI: https://doi.org/10.2215/CJN.08900719
Terumasa Hayashi
1Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Shoichi Maruyama
2Department of Nephrology, Nagoya University, Nagoya, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Masaomi Nangaku
3Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ichiei Narita
4Division of Clinical Nephrology and Rheumatology, Niigata University, Niigata, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • ORCID record for Ichiei Narita
Hideki Hirakata
5Fukuoka Renal Clinic, Fukuoka, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Kenichiro Tanabe
6Division of Health Data Science, Translational Research Center for Medical Innovation, Kobe, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Satoshi Morita
7Biomedical Statistics and Bioinformatics, Kyoto University, Kyoto, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yoshiharu Tsubakihara
8Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Enyu Imai
9Nakayamadera Imai Clinic, Takarazuka, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Tadao Akizawa
10Division of Nephrology, Showa University School of Medicine, Tokyo, Japan
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data Supps
  • Info & Metrics
  • View PDF
Loading

This article requires a subscription to view the full text. If you have a subscription you may use the login form below to view the article. Access to this article can also be purchased.

Visual Abstract

Figure1
  • Download figure
  • Open in new tab
  • Download powerpoint

Abstract

Background and objectives Large, randomized, controlled trials targeting higher hemoglobin level with erythropoiesis-stimulating agents for Western patients with CKD showed harm. However, the effect of anemia correction using erythropoiesis-stimulating agents may differ between CKD subpopulations. The Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease study, a multicenter, randomized, open-label, parallel-group study, aimed to examine the effect of targeting hemoglobin levels of 11–13 g/dl using darbepoetin alfa with reference to a low-hemoglobin target of 9–11 g/dl on kidney outcome in patients with advanced CKD without diabetes in Japan.

Design, setting, participants, & measurements We enrolled 491 patients with CKD without diabetes, and an eGFR of 8–20 ml/min per 1.73 m2. Of these 491 patients, 239 and 240 were ultimately assigned to the high- and low-hemoglobin groups, respectively (12 patients were excluded). The primary outcome was a kidney composite end point (starting maintenance dialysis, kidney transplantation, eGFR≤6 ml/min per 1.73 m2, and 50% reduction in eGFR).

Results Mean hemoglobin levels were 11.2±1.1 and 10.0±0.9 g/dl in the high- and low-hemoglobin groups, respectively, during the mean study period of 73.5±29.7 weeks. The kidney composite end point occurred in 105 (44%) and 116 (48%) patients in the high- and low-hemoglobin groups, respectively (log-rank test; P=0.32). The adjusted Cox proportional hazards model showed that the hazard ratio for the high- versus low-hemoglobin group was 0.78 (95% confidence interval, 0.60 to 1.03; P=0.08). Cardiovascular events occurred in 19 (8%) and 16 (7%) patients in each group, respectively, with no significant between-group difference (log-rank test; P=0.66).

Conclusions Targeting a higher hemoglobin level (11–13 g/dl) with darbepoetin alfa did not improve kidney outcome compared with targeting a lower hemoglobin level (9–11 g/dl) in patients with advanced CKD without diabetes.

Clinical Trial registry name and registration number Prevention of ESKD by Darbepoetin Alfa in CKD Patients with Non-diabetic Kidney Disease (PREDICT), NCT01581073.

  • chronic kidney disease
  • hemoglobin
  • renal outcome
  • non-diabetic
  • Darbepoetin alfa
  • Hematinics
  • renal dialysis
  • glomerular filtration rate
  • kidney transplantation
  • Proportional Hazards Models
  • Renal Insufficiency, Chronic
  • diabetes mellitus
  • Hemoglobins
  • Cardiovascular Diseases
  • Received July 30, 2019.
  • Accepted March 6, 2020.
  • Copyright © 2020 by the American Society of Nephrology
View Full Text

If you do not have an account on CJASN or JASN, you will need to create one.  See the instructions below for details on how to create an account. 

Log in using your username and password

Forgot your user name or password?

Log in through your institution

You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.

Purchase access

You will have access to the article for 24 hours.  

When you create an account, you will be asked for your name, email address and other information.  Just like commercial web sites, we do need details from you in order to complete your purchase of an article.  Select the "Create an Account" link to create your account. 

You will then be asked to register a user name, email address and you will need to create a password that is at least eight characters in length. As you move through the registration page, you will have to verify you are a person by completing a Captcha request.   Lastly, your first and last name will be required. 

Once your information is successfully saved, the system will redisplay the home page of the journal.  From there, navigate back to the article to purchase.  Select the article and at the bottom of the page, use the credentials you just created to login. The article will be added to your shopping cart.  You can continue to navigate across JASN and CJASN adding to your cart from both journals. When you are ready to complete your purchse, select the Shopping Cart from the upper right hand corner of the page and follow the onscreen instructions. 

PreviousNext
Back to top

In this issue

Clinical Journal of the American Society of Nephrology: 15 (5)
Clinical Journal of the American Society of Nephrology
Vol. 15, Issue 5
May 07, 2020
  • Table of Contents
  • Table of Contents (PDF)
  • About the Cover
  • Index by author
View Selected Citations (0)
Print
Download PDF
Sign up for Alerts
Email Article
Thank you for your help in sharing the high-quality science in CJASN.
Enter multiple addresses on separate lines or separate them with commas.
Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial
(Your Name) has sent you a message from American Society of Nephrology
(Your Name) thought you would like to see the American Society of Nephrology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial
Terumasa Hayashi, Shoichi Maruyama, Masaomi Nangaku, Ichiei Narita, Hideki Hirakata, Kenichiro Tanabe, Satoshi Morita, Yoshiharu Tsubakihara, Enyu Imai, Tadao Akizawa, for the PREDICT Investigators
CJASN May 2020, 15 (5) 608-615; DOI: 10.2215/CJN.08900719

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Request Permissions
Share
Darbepoetin Alfa in Patients with Advanced CKD without Diabetes: Randomized, Controlled Trial
Terumasa Hayashi, Shoichi Maruyama, Masaomi Nangaku, Ichiei Narita, Hideki Hirakata, Kenichiro Tanabe, Satoshi Morita, Yoshiharu Tsubakihara, Enyu Imai, Tadao Akizawa, for the PREDICT Investigators
CJASN May 2020, 15 (5) 608-615; DOI: 10.2215/CJN.08900719
del.icio.us logo Digg logo Reddit logo Twitter logo CiteULike logo Facebook logo Google logo Mendeley logo
  • Tweet Widget
  • Facebook Like

Jump to section

  • Article
    • Visual Abstract
    • Abstract
    • Introduction
    • Materials and Methods
    • Results
    • Discussion
    • Disclosures
    • Funding
    • Acknowledgments
    • Supplemental Material
    • Footnotes
    • References
  • Figures & Data Supps
  • Info & Metrics
  • View PDF

More in this TOC Section

Original Articles

  • Short-Duration Prednisolone in Children with Nephrotic Syndrome Relapse
  • Associations between Deprivation, Geographic Location, and Access to Pediatric Kidney Care in the United Kingdom
  • Variability in Culture-Negative Peritonitis Rates in Pediatric Peritoneal Dialysis Programs in the United States
Show more Original Articles

Chronic Kidney Disease

  • NAT8 Variants, N-Acetylated Amino Acids, and Progression of CKD
  • Effect of Urate-Lowering Therapy on Cardiovascular and Kidney Outcomes
  • Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD
Show more Chronic Kidney Disease

Cited By...

  • No citing articles found.
  • Google Scholar

Similar Articles

Related Articles

  • PubMed
  • Google Scholar

Keywords

  • chronic kidney disease
  • hemoglobin
  • renal outcome
  • non-diabetic
  • Darbepoetin alfa
  • Hematinics
  • renal dialysis
  • glomerular filtration rate
  • kidney transplantation
  • Proportional Hazards Models
  • Renal Insufficiency, Chronic
  • diabetes mellitus
  • Hemoglobins
  • cardiovascular diseases

Articles

  • Current Issue
  • Early Access
  • Subject Collections
  • Article Archive
  • ASN Meeting Abstracts

Information for Authors

  • Submit a Manuscript
  • Trainee of the Year
  • Author Resources
  • ASN Journal Policies
  • Reuse/Reprint Policy

About

  • CJASN
  • ASN
  • ASN Journals
  • ASN Kidney News

Journal Information

  • About CJASN
  • CJASN Email Alerts
  • CJASN Key Impact Information
  • CJASN Podcasts
  • CJASN RSS Feeds
  • Editorial Board

More Information

  • Advertise
  • ASN Podcasts
  • ASN Publications
  • Become an ASN Member
  • Feedback
  • Follow on Twitter
  • Password/Email Address Changes
  • Subscribe

© 2021 American Society of Nephrology

Print ISSN - 1555-9041 Online ISSN - 1555-905X

Powered by HighWire