Erythropoietin Resistance in Anemia of Chronic Kidney Disease - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00526747

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

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

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

Further study details as provided by Duke University:

Estimated 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

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:

Rossert J, Gassmann-Mayer C, Frei D, McClellan W. Prevalence and predictors of epoetin hyporesponsiveness in chronic kidney disease patients. Nephrol Dial Transplant. 2007 Mar;22(3):794-800. Epub 2007 Jan 8.

McClellan WM, Flanders WD, Langston RD, Jurkovitz C, Presley R. Anemia and renal insufficiency are independent risk factors for death among patients with congestive heart failure admitted to community hospitals: a population-based study. J Am Soc Nephrol. 2002 Jul;13(7):1928-36.

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.

McMahon LP, Mason K, Skinner SL, Burge CM, Grigg LE, Becker GJ. Effects of haemoglobin normalization on quality of life and cardiovascular parameters in end-stage renal failure. Nephrol Dial Transplant. 2000 Sep;15(9):1425-30.

Evans RW, Rader B, Manninen DL. The quality of life of hemodialysis recipients treated with recombinant human erythropoietin. Cooperative Multicenter EPO Clinical Trial Group. JAMA. 1990 Feb 9;263(6):825-30.

Wolcott DL, Marsh JT, La Rue A, Carr C, Nissenson AR. Recombinant human erythropoietin treatment may improve quality of life and cognitive function in chronic hemodialysis patients. Am J Kidney Dis. 1989 Dec;14(6):478-85.

Strippoli GF, Craig JC, Manno C, Schena FP. Hemoglobin targets for the anemia of chronic kidney disease: a meta-analysis of randomized, controlled trials. J Am Soc Nephrol. 2004 Dec;15(12):3154-65.

Obrador GT, Roberts T, St Peter WL, Frazier E, Pereira BJ, Collins AJ. Trends in anemia at initiation of dialysis in the United States. Kidney Int. 2001 Nov;60(5):1875-84.

Zhang Y, Thamer M, Stefanik K, Kaufman J, Cotter DJ. Epoetin requirements predict mortality in hemodialysis patients. Am J Kidney Dis. 2004 Nov;44(5):866-76.

Humphries JE. Anemia of renal failure. Use of erythropoietin. Med Clin North Am. 1992 May;76(3):711-25. Review.

Stenvinkel P. Anaemia and inflammation: what are the implications for the nephrologist? Nephrol Dial Transplant. 2003 Nov;18 Suppl 8:viii17-22. Review.

Kimmel PL, Phillips TM, Simmens SJ, Peterson RA, Weihs KL, Alleyne S, Cruz I, Yanovski JA, Veis JH. Immunologic function and survival in hemodialysis patients. Kidney Int. 1998 Jul;54(1):236-44.

Macdougall IC, Cooper AC. Erythropoietin resistance: the role of inflammation and pro-inflammatory cytokines. Nephrol Dial Transplant. 2002;17 Suppl 11:39-43. Review.

Nemeth E, Rivera S, Gabayan V, Keller C, Taudorf S, Pedersen BK, Ganz T. IL-6 mediates hypoferremia of inflammation by inducing the synthesis of the iron regulatory hormone hepcidin. J Clin Invest. 2004 May;113(9):1271-6.

Bologa RM, Levine DM, Parker TS, Cheigh JS, Serur D, Stenzel KH, Rubin AL. Interleukin-6 predicts hypoalbuminemia, hypocholesterolemia, and mortality in hemodialysis patients. Am J Kidney Dis. 1998 Jul;32(1):107-14.

Sitter T, Bergner A, Schiffl H. Dialysate related cytokine induction and response to recombinant human erythropoietin in haemodialysis patients. Nephrol Dial Transplant. 2000 Aug;15(8):1207-11.

Touam M, Guery B, Goupy C, Menoyo V, Drueke T. Hypothyroidism and resistance to human recombinant erythropoietin. Nephrol Dial Transplant. 2004 Apr;19(4):1020-1. No abstract available.

Danielson B. R-HuEPO hyporesponsiveness--who and why? Nephrol Dial Transplant. 1995;10 Suppl 2:69-73.

Goicoechea M, Martin J, de Sequera P, Quiroga JA, Ortiz A, Carreno V, Caramelo C. Role of cytokines in the response to erythropoietin in hemodialysis patients. Kidney Int. 1998 Oct;54(4):1337-43.

Nemeth E, Tuttle MS, Powelson J, Vaughn MB, Donovan A, Ward DM, Ganz T, Kaplan J. Hepcidin regulates cellular iron efflux by binding to ferroportin and inducing its internalization. Science. 2004 Dec 17;306(5704):2090-3. Epub 2004 Oct 28.

Responsible Party:	Duke University Medical Center ( Jula Inrig, MD )
Study ID Numbers:	8578-07-6R1ER
Study First Received:	September 6, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00526747
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009