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

This study has been terminated.
Sponsor:
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
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00457535
First received: April 5, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition
Renal Dialysis

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Recombinant Human Erythropoietin Dose, Serum Adiponectin, and All-Cause Mortality in Patients Beginning Hemodialysis

Resource links provided by NLM:


Further study details as provided by Hamamatsu University:

Study Start Date: August 2000
Estimated Study Completion Date: July 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457535

Sponsors and Collaborators
Hamamatsu University
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
Investigators
Principal Investigator: Naro Ohashi, MD,PhD First Department of Medicine, Hamamatsu University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00457535     History of Changes
Other Study ID Numbers: 710808
Study First Received: April 5, 2007
Last Updated: April 5, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:
recombinant human erythropoietin
adiponectin
mortality

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014