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TerminatedNCT00457535Updated Apr 6, 2007

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

An observational study in Renal Dialysis, sponsored by Hamamatsu University. Terminated. Per ClinicalTrials.gov, last updated 2007-04-06.

Sponsored by Hamamatsu University · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Sex
All
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Study summary

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.

Read the detailed description

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.

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.

02

Conditions studied

  • Renal Dialysis

Keywords

  • recombinant human erythropoietin
  • adiponectin
  • mortality
03

In context

Lead sponsor

Hamamatsu University is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • nothing particular
05

Study design

Observational model
Defined population
Time perspective
Prospective
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00457535
Lead sponsor
Hamamatsu University
Collaborators
Shitoro Clinic, Fujinomiya City Hospital, Iwata City Hospital, Seirei Mikatabara General Hospital, Seirei Hamamatsu General Hospital, Hamana Clinic, Tadokoro Clinic, Makoto Clinic, Maruyama Memorial General Hospital, Sun-Sanaru Clinic
First posted
Apr 6, 2007
Start date
Aug 2000
Completion
Jul 2004
Last update
Apr 6, 2007

Study contacts

Naro Ohashi, MD,PhD
principal investigator · First Department of Medicine, Hamamatsu University School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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