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
  Purpose

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


Condition
Renal Dialysis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Resource links provided by NLM:


Further study details as provided by Hamamatsu University:

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00308698

Sponsors and Collaborators
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
Investigators
Principal Investigator: Naro Ohashi, M.D., Ph.D. First Department of Medicine, Hamamatsu University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00308698     History of Changes
Other Study ID Numbers: 0808
Study First Received: March 29, 2006
Last Updated: March 29, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:
recombinant human erythropoietin
adiponectin
mortality

ClinicalTrials.gov processed this record on September 18, 2014