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

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.

Study Overview

• Status: Terminated
• Conditions: Renal Dialysis

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Hamamatsu University
• Collaborators: Maruyama Memorial General Hospital; Seirei Hamamatsu General Hospital; Iwata City Hospital; Shitoro Clinic; Fujinomiya City Hospital; Seirei Mikatabara General Hospital; Hamana Clinic; Tadokoro Clinic; Makoto Clinic; Sun-Sanaru Clinic
• Investigators: Principal Investigator: Naro Ohashi, MD,PhD, First Department of Medicine, Hamamatsu University School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2000
• Study Completion: July 1, 2004

Study Registration Dates

• First Submitted: April 5, 2007
• First Submitted That Met QC Criteria: April 5, 2007
• First Posted (Estimate): April 6, 2007

Study Record Updates

• Last Update Posted (Estimate): April 6, 2007
• Last Update Submitted That Met QC Criteria: April 5, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: mortality; adiponectin; recombinant human erythropoietin
• Other Study ID Numbers: 710808