Erythropoietin Resistance in Anemia of Chronic Kidney Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 6, 2007

Last Updated Date

November 6, 2008

Start Date ^†

August 2007

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00526747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Erythropoietin Resistance in Anemia of Chronic Kidney Disease

Official Title ^†

Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease

Brief Summary

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

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Other, Other

Condition ^†

Anemia
Kidney Failure
Erythropoietin

Intervention ^†

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00526747

Responsible Party

Jula Inrig, MD, Duke University Medical Center

Secondary IDs ^††

Study Sponsor ^†

Duke University

Collaborators ^††

Investigators ^†

Principal Investigator:	Jula Inrig, MD, MHS	Duke University
Principal Investigator:	Lynda Szczech, MD	Duke University
Principal Investigator:	Suzanne K Bryskin, MD	Duke University

Information Provided By

Duke University

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.