Erythropoietin Resistance in Anemia of Chronic Kidney Disease
Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT00526747
Collaborator
(none)
32
2
10
16
1.6
Study Details
Study Description
Brief Summary
Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
32 participants
Official Title:
Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease
Study Start Date
:
Aug 1, 2007
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jun 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Durham Nephrology Anemia Clinic | Durham | North Carolina | United States | 27704 |
| 2 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Danielson B. R-HuEPO hyporesponsiveness--who and why? Nephrol Dial Transplant. 1995;10 Suppl 2:69-73.
- 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.
- 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.
- Humphries JE. Anemia of renal failure. Use of erythropoietin. Med Clin North Am. 1992 May;76(3):711-25. 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Stenvinkel P. Anaemia and inflammation: what are the implications for the nephrologist? Nephrol Dial Transplant. 2003 Nov;18 Suppl 8:viii17-22. Review.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT00526747
Other Study ID Numbers:
- Pro00008469
First Posted:
Sep 10, 2007
Last Update Posted:
Apr 11, 2013
Last Verified:
Nov 1, 2008
Additional relevant MeSH terms: