Erythropoietin Resistance in Anemia of Chronic Kidney Disease

This study has been completed.
Information provided by (Responsible Party):
Duke University Identifier:
First received: September 6, 2007
Last updated: April 9, 2013
Last verified: November 2008
Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.

Kidney Failure

Study Type: Observational
Official Title: Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by Duke University:

Enrollment: 32
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Patients with CKD (estimated GFR < 60cc/min) not on hemodialysis who are receiving greater than or equal to 100IU/kg/week of epoetin alpha and/or 1mcg/kg/week darbepoetin to obtain target hemoglobin or hematocrit.
Patients with CKD (estimated GFR < 60cc/min) not on hemodialysis who are requiring <100IU/kg/week of epoetin alpha and/or 1mcg/kg/week of darbepoetin to obtain target hemoglobin/hematocrit.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CKD anemia clinic patients

Inclusion Criteria:

  • prevalent patients greater than or equal to 18 years old with CKD defined as a glomerular filtration rate < 60 cc/min

Exclusion Criteria:

  • active GI bleeding or history of GI bleed in the prior 3 months
  • uncontrolled hyperparathyroidism (PTH>500)
  • untreated iron deficiency (transferrin saturation < 20% and ferritin < 100
  • overt infection
  • active hemolysis
  • hemoglobinopathies
  • known adverse response to erythropoietin
  • prior kidney transplant
  • aluminum toxicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00526747

United States, North Carolina
Duke University Medical Center Anemia Clinic
Durham, North Carolina, United States, 27705
Durham Nephrology Anemia Clinic
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
Principal Investigator: Jula Inrig, MD, MHS Duke University
Principal Investigator: Lynda Szczech, MD Duke University
Principal Investigator: Suzanne K Bryskin, MD Duke University
  More Information

U.S. Renal Data System, USRDS 2005 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Disease, Bethesda, MD, 2005.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT00526747     History of Changes
Other Study ID Numbers: Pro00008469
Study First Received: September 6, 2007
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Epoetin alfa
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015