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

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00457535
• Other study ID #: 710808
• Status: Terminated
• Phase: N/A
• First received: April 5, 2007
• Last updated: April 5, 2007
• Start date: August 2000
• Est. completion date: July 2004

Study information

• Verified date: April 2007
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Renal Dialysis

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Hamamatsu University	Fujinomiya City Hospital, Hamana Clinic, Iwata City Hospital, Makoto Clinic, Maruyama Memorial General Hospital, Seirei Hamamatsu General Hospital, Seirei Mikatabara General Hospital, Shitoro Clinic, Sun-Sanaru Clinic, Tadokoro Clinic