Clinical trial NCT00308698: Study of the Relationship Between rHuEPO Dose, Serum ADPN, and Mortality in Patients Beginning Hemodialysis (HD)
Official title: Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Dialysis
Keywords: recombinant human erythropoietin
adiponectin
mortality
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
Collaborators: name: Fujinomiya City Hospital
name: Iwata City Hospital
name: Seirei Mikatabara General Hospital
name: Seirei Hamamatsu General Hospital
name: Hamana Clinic
name: Tadokoro Clinic
name: Makoto Clinic
name: Maruyama Memorial General Hospital
name: Shitoro Clinic
name: Sun-Sanaru Clinic
First posted: 2006-03-30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Department of Medicine, Hamamatsu University School of Medicine
name: Naro Ohashi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: