Erythropoietin Resistance in Anemia of Chronic Kidney Disease
9. april 2013 opdateret af: Duke University
Novel Biomarkers of Erythropoietin Resistant Anemia Among Patients With Chronic Kidney Disease
Our goal of this pilot project is to identify inflammatory biomarkers that correlate with epo-resistance among CKD patients.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
32
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27704
- Durham Nephrology Anemia Clinic
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Durham, North Carolina, Forenede Stater, 27705
- Duke University Medical Center Anemia Clinic
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
CKD anemia clinic patients
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Kohorter og interventioner
Gruppe / kohorte |
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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.
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lynda Szczech, MD, Duke University
- Ledende efterforsker: Jula Inrig, MD, MHS, Duke University
- Ledende efterforsker: Suzanne K Bryskin, MD, Duke University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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. doi: 10.1126/science.1104742. Epub 2004 Oct 28.
- 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. doi: 10.1172/JCI20945.
- 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. doi: 10.1046/j.1523-1755.1998.00981.x.
- 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. doi: 10.1053/ajkd.1998.v32.pm9669431.
- 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. doi: 10.1093/ndt/gfl716. 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. doi: 10.1097/01.asn.0000018409.45834.fa.
- 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. doi: 10.1093/ndt/15.9.1425.
- 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. doi: 10.1016/s0272-6386(89)80148-9.
- 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. doi: 10.1097/01.ASN.0000145436.09176.A7.
- 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. doi: 10.1046/j.1523-1755.2001.00002.x.
- 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. doi: 10.1016/s0025-7125(16)30349-2.
- Stenvinkel P. Anaemia and inflammation: what are the implications for the nephrologist? Nephrol Dial Transplant. 2003 Nov;18 Suppl 8:viii17-22. doi: 10.1093/ndt/gfg1086.
- Macdougall IC, Cooper AC. Erythropoietin resistance: the role of inflammation and pro-inflammatory cytokines. Nephrol Dial Transplant. 2002;17 Suppl 11:39-43. doi: 10.1093/ndt/17.suppl_11.39.
- 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. doi: 10.1093/ndt/15.8.1207.
- 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. doi: 10.1093/ndt/gfg556. No abstract available.
- Danielson B. R-HuEPO hyporesponsiveness--who and why? Nephrol Dial Transplant. 1995;10 Suppl 2:69-73. doi: 10.1093/ndt/10.supp2.69.
- 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. doi: 10.1046/j.1523-1755.1998.00084.x.
- Inrig JK, Bryskin SK, Patel UD, Arcasoy M, Szczech LA. Association between high-dose erythropoiesis-stimulating agents, inflammatory biomarkers, and soluble erythropoietin receptors. BMC Nephrol. 2011 Dec 12;12:67. doi: 10.1186/1471-2369-12-67.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2007
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
6. september 2007
Først indsendt, der opfyldte QC-kriterier
6. september 2007
Først opslået (Skøn)
10. september 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. april 2013
Sidst verificeret
1. november 2008
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00008469
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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