We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457535
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Time Perspective: Prospective
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00457535     History of Changes
Other Study ID Numbers: 710808
First Submitted: April 5, 2007
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
Last Verified: April 2007

Keywords provided by Hamamatsu University:
recombinant human erythropoietin
adiponectin
mortality

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics