Erythropoietin Resistance in Anemia of Chronic Kidney Disease

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526747
• Other study ID #: Pro00008469
• Status: Completed
• Phase: N/A
• First received: September 6, 2007
• Last updated: April 9, 2013
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: November 2008
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Anemia
• Erythropoietin
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Duke University Medical Center Anemia Clinic	Durham	North Carolina
United States	Durham Nephrology Anemia Clinic	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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

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. — View Citation

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

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Touam M, Guéry B, Goupy C, Menoyo V, Drüeke T. Hypothyroidism and resistance to human recombinant erythropoietin. Nephrol Dial Transplant. 2004 Apr;19(4):1020-1. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references