Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)
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|ClinicalTrials.gov Identifier: NCT00308698|
Recruitment Status : Completed
First Posted : March 30, 2006
Last Update Posted : March 30, 2006
|Condition or disease|
Background: Responsiveness of recombinant human erythropoietin (rHuEPO) is known to be related with body fatness in hemodialysis (HD) patients. Adiponectin (ADPN) is inversely associated with body fat mass, and in healthy subjects, low ADPN is a predictor of mortality. Recently, higher rHuEPO dose itself is demonstrated to be associated with poor prognosis. So, in this study, we prospectively examined the relationship between rHuEPO dose, serum ADPN, and mortality in patients beginning HD.
Methods: We selected 85 patients (51 men/34 women, age; 64±15 years) who survived for more than 3 months after the start of HD. After determining initial rHuEPO dosage, we followed the patients for 3 years, and examined an association between rHuEPO dose, serum ADPN, and all-cause mortality.
Results: We could follow totally 74 out of 85 patients for 3 years; 59 patients were survived, but 15 patients expired. Dosage of rHuEPO was significantly and negatively correlated with body mass index (BMI) (r=-0.44, p<0.01) and positively with serum ADPN (r=0.29, p<0.02), but not with leptin. Cox-hazards regression analysis adjusted by age, sex and underlying kidney disease revealed that rHuEPO dose and serum ADPN, as well as nutritional parameter such as protein catabolic rate became significant determinants of 3-year mortality. There was a 12.7% risk increase for 10U/kg/week increase in rHuEPO dose and 1.3% increase for 1µg/ml increment of serum ADPN for the 3-year of follow-up.
Conclusion: High rHuEPO requirement and elevated serum ADPN were significant determinants of long-term mortality in patients who started HD therapy.
|Study Type :||Observational|
|Observational Model:||Defined Population|
|Official Title:||Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis|
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308698
|Principal Investigator:||Naro Ohashi, M.D., Ph.D.||First Department of Medicine, Hamamatsu University School of Medicine|