Impact of Dialysis Modality on Hepcidin and Iron Metabolism

NCT ID: NCT01723111

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-08-31

Brief Summary

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* Dialysis modality may influence the oxidative stress and proinflammatory cytokines in ESRD patients.
* Dialysis modality may affect hepcidin
* Dialysis modality may influence iron and ESA requirements.

Detailed Description

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It has been considered that PD patients tended to be less anemic and require lower ESA dose than HD patients. In addition, it was also known that the level of oxidative stress and inflammatory cytokines tended to be lower in PD patients than HD patients. And hepcidin synthesis is markedly increased during inflammation. Altogether, Lower ESA requirement in PD patients may be associated with lower hepcidin level due to lower inflammatory state compared with HD patients.

Conditions

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End-stage Renal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Peritoneal dialysis

start PD

No interventions assigned to this group

Hemodialysis

start HD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Age 18 years or older
* Dialysis treatment was expected over 3 months
* In HD patients, regular hemodialysis 4 h a session more than two times a week
* In PD patients, over 2 exchange with more than 1.5 L solution

Exclusion Criteria

* Poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite medication requiring hospitalization or interruption of ESA treatment
* Significant acute or chronic bleeding such as overt gastrointestinal bleeding within the previous 3 months
* Active malignant disease (except non-melanoma skin cancer and patients with malignant disease who have been disease-free for at least the 5 previous years are eligible)
* Acute infection
* Hemolysis
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Megaloblastic anemia
* Platelet count \>500 x 109/L or \<100 x 109/L
* Pure red call aplasia
* Epileptic seizure during previous 3 months
* Women of childbearing potential without effective contraception
* Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol
* Planned elective surgery during the study period except for cataract surgery or laser photocoagulation
* Life expectancy less than 12 month
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Fresenius Medical Care North America

INDUSTRY

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong-Lim Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-Lim Kim

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine

Locations

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Daegu Fatima Hospital

Daegu, , South Korea

Site Status

Dongsan Medical Center

Daegu, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Yeungnam University College of Medicine

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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Malyszko J, Malyszko JS, Kozminski P, Mysliwiec M. Type of renal replacement therapy and residual renal function may affect prohepcidin and hepcidin. Ren Fail. 2009;31(10):876-83. doi: 10.3109/08860220903216071.

Reference Type BACKGROUND
PMID: 20030521 (View on PubMed)

Other Identifiers

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knuhhermes

Identifier Type: -

Identifier Source: org_study_id

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