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

NCT ID: NCT00457535

Last Updated: 2007-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-07-31

Brief Summary

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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

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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.

Conditions

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Renal Dialysis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shitoro Clinic

UNKNOWN

Sponsor Role collaborator

Fujinomiya City Hospital

OTHER

Sponsor Role collaborator

Iwata City Hospital

OTHER

Sponsor Role collaborator

Seirei Mikatabara General Hospital

UNKNOWN

Sponsor Role collaborator

Seirei Hamamatsu General Hospital

OTHER

Sponsor Role collaborator

Hamana Clinic

OTHER

Sponsor Role collaborator

Tadokoro Clinic

UNKNOWN

Sponsor Role collaborator

Makoto Clinic

UNKNOWN

Sponsor Role collaborator

Maruyama Memorial General Hospital

OTHER

Sponsor Role collaborator

Sun-Sanaru Clinic

UNKNOWN

Sponsor Role collaborator

Hamamatsu University

OTHER

Sponsor Role lead

Principal Investigators

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Naro Ohashi, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Medicine, Hamamatsu University School of Medicine

Other Identifiers

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710808

Identifier Type: -

Identifier Source: org_study_id