Erythropoietin Resistance in Anemia of Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00526747
First received: September 6, 2007
Last updated: April 9, 2013
Last verified: November 2008
  Purpose

Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.


Condition
Anemia
Kidney Failure
Erythropoietin

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)
Groups/Cohorts
Epo-resistant
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.
Epo-responsive
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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00526747

Locations
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
Investigators
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

Publications:
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov 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:
Anemia
Renal Insufficiency, Chronic
Kidney Diseases
Renal Insufficiency
Hematologic Diseases
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014