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Erythropoietin Resistance in Anemia of Chronic Kidney Disease

Primary Purpose

Anemia, Kidney Failure, Erythropoietin

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham Nephrology Anemia Clinic
  • Duke University Medical Center Anemia Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Epo-resistant

Epo-responsive

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2007
Last Updated
April 9, 2013
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00526747
Brief Title
Erythropoietin Resistance in Anemia of Chronic Kidney Disease
Official Title
Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease
Study Type
Observational

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Kidney Failure, Erythropoietin

7. Study Design

Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epo-resistant
Arm Description
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.
Arm Title
Epo-responsive
Arm Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
CKD anemia clinic patients
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jula Inrig, MD, MHS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynda Szczech, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne K Bryskin, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Nephrology Anemia Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center Anemia Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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derived

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Erythropoietin Resistance in Anemia of Chronic Kidney Disease

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