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Erythropoietin Resistance in Anemia of Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00526747
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Duke University

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

Condition or disease
Anemia Kidney Failure Erythropoietin

Study Design
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Study Type : Observational
Actual Enrollment : 32 participants
Official Title: Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease
Study Start Date : August 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526747


Locations
United States, North Carolina
Durham Nephrology Anemia Clinic
Durham, North Carolina, United States, 27704
Duke University Medical Center Anemia Clinic
Durham, North Carolina, United States, 27705
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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.

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
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: November 2008

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Hematologic Diseases
Urologic Diseases
Epoetin Alfa
Hematinics