Impact of Dialysis Modality on Hepcidin and Iron Metabolism

End-stage Renal Disease Clinical Trial

— HERMES  

Official title:

A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723111
• Other study ID #: knuhhermes
• Status: Completed
• Phase: N/A
• First received: November 2, 2012
• Last updated: August 19, 2017
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Daegu Fatima Hospital	Daegu
Korea, Republic of	Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University College of Medicine	Daegu

Sponsors (3)

Lead Sponsor	Collaborator
Kyungpook National University	Fresenius Medical Care North America, Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESA (Erythrocyte stimulating agents) dose	We will compare ESA dose between PD patients and HD patients	six months
Secondary	IV iron treatment (% of patients)	We will compare IV iron treatment (% of patients) between PD patients and HD patients	six months
Secondary	Hepcidin level	We will compare hepcidin level between PD patients and HD patients	six months
Secondary	hs-CRP	We will compare hs-CRP level between PD patients and HD patients	six months
Secondary	Myeloperoxidase	We will compare myeloperoxidase between PD patients and HD patients	six months
Secondary	Transfusion rate	We will compare transfusion rate ( % of patients) between PD patients and HD patients	six months
Secondary	TNF-a	We will compare TNF-a between PD patients and HD patients	six months
Secondary	IL-6	We will compare IL-6 between PD patients and HD patients	six months
Secondary	Total antioxidant capacity	We will compare total antioxidant capacity between PD patients and HD patients	six months