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

Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00457535
Enrollment
Unknown
Registered
2007-04-06
Start date
2000-08-31
Completion date
2004-07-31
Last updated
2007-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

recombinant human erythropoietin, adiponectin, mortality

Brief 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.

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.

Interventions

None listed

Sponsors

Shitoro Clinic
CollaboratorUNKNOWN
Fujinomiya City Hospital
CollaboratorOTHER
Iwata City Hospital
CollaboratorOTHER
Seirei Mikatabara General Hospital
CollaboratorUNKNOWN
Seirei Hamamatsu General Hospital
CollaboratorOTHER
Hamana Clinic
CollaboratorOTHER
Tadokoro Clinic
CollaboratorUNKNOWN
Makoto Clinic
CollaboratorUNKNOWN
Maruyama Memorial General Hospital
CollaboratorOTHER
Sun-Sanaru Clinic
CollaboratorUNKNOWN
Hamamatsu University
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

* nothing particular

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026