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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308698
First Posted: March 30, 2006
Last Update Posted: March 30, 2006
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:
Fujinomiya City Hospital
Iwata City Hospital
Seirei Mikatabara General Hospital
Seirei Hamamatsu General Hospital
Hamana Clinic
Tadokoro Clinic
Makoto Clinic
Maruyama Memorial General Hospital
Shitoro Clinic
Sun-Sanaru Clinic
Information provided by:
Hamamatsu University
  Purpose
High recombinant human erythropoietin requirement and elevated serum adiponectin were significant determinants of long-term mortality in patients who started hemodialysis therapy.

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:

Detailed Description:

Background: 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.

Methods: 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.

Results: 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.

Conclusion: High rHuEPO requirement and elevated serum ADPN were significant determinants of long-term mortality in patients who started HD therapy.

  Eligibility

Information from the National Library of Medicine

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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): NCT00308698


Sponsors and Collaborators
Hamamatsu University
Fujinomiya City Hospital
Iwata City Hospital
Seirei Mikatabara General Hospital
Seirei Hamamatsu General Hospital
Hamana Clinic
Tadokoro Clinic
Makoto Clinic
Maruyama Memorial General Hospital
Shitoro Clinic
Sun-Sanaru Clinic
Investigators
Principal Investigator: Naro Ohashi, M.D., Ph.D. First Department of Medicine, Hamamatsu University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00308698     History of Changes
Other Study ID Numbers: 0808
First Submitted: March 29, 2006
First Posted: March 30, 2006
Last Update Posted: March 30, 2006
Last Verified: July 2004

Keywords provided by Hamamatsu University:
recombinant human erythropoietin
adiponectin
mortality

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics


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