Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)

This study has been completed.
Sponsor:
Collaborators:
Fujinomiya City Hospital
Iwata City Hospital
Seirei Mikatabara General Hospital
Seirei Hamamatsu General Hospital
Hamana Clinic
Tadokoro Clinic
Makoto Clinic
Maruyama Memorial General Hospital
Shitoro Clinic
Sun-Sanaru Clinic
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00308698
First received: March 29, 2006
Last updated: NA
Last verified: July 2004
History: No changes posted

March 29, 2006
March 29, 2006
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Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)
Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

High recombinant human erythropoietin requirement and elevated serum adiponectin were significant determinants of long-term mortality in patients who started hemodialysis therapy.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Renal Dialysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • patients who had first started hemodialysis therapy from August 2000 to May 2001 in 11 dialysis centers in Shizuoka prefecture area.

Exclusion Criteria:

  • nothing particular
Both
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Contact information is only displayed when the study is recruiting subjects
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NCT00308698
0808
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Hamamatsu University
  • Fujinomiya City Hospital
  • Iwata City Hospital
  • Seirei Mikatabara General Hospital
  • Seirei Hamamatsu General Hospital
  • Hamana Clinic
  • Tadokoro Clinic
  • Makoto Clinic
  • Maruyama Memorial General Hospital
  • Shitoro Clinic
  • Sun-Sanaru Clinic
Principal Investigator: Naro Ohashi, M.D., Ph.D. First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu University
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP