End-stage Renal DiseaseHERMESNCT01723111
Impact of Dialysis Modality on Hepcidin and Iron Metabolism
An observational study of End-stage Renal Disease, run by Kyungpook National University Hospital at 4 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- How many people
- 120 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2012to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New ESRD patients whose dialysis treatment is expected over 3 months
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Daegu Fatima Hospital
Daegu, 700-721
Dongsan Medical Center
Daegu, 700-721
Kyungpook National University Hospital
Daegu, 700-721
Yeungnam University College of Medicine
Daegu, 705-717
About this study
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin
- 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.
Read the detailed 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.
- Conditions
- End-stage Renal Disease
- Keywords
- hepcidin, ESA, hemodialysis, peritoneal dialysis, iron metabolism, dialysis modality
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis | start PD | |
| Hemodialysis | start HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESA (Erythrocyte stimulating agents) dose
We will compare ESA dose between PD patients and HD patients
Measured: six months
Secondary outcomes (8)
IV iron treatment (% of patients)
We will compare IV iron treatment (% of patients) between PD patients and HD patients
Measured: six months
Hepcidin level
We will compare hepcidin level between PD patients and HD patients
Measured: six months
hs-CRP
We will compare hs-CRP level between PD patients and HD patients
Measured: six months
Myeloperoxidase
We will compare myeloperoxidase between PD patients and HD patients
Measured: six months
Transfusion rate
We will compare transfusion rate ( % of patients) between PD patients and HD patients
Measured: six months
TNF-a
We will compare TNF-a between PD patients and HD patients
Measured: six months
IL-6
We will compare IL-6 between PD patients and HD patients
Measured: six months
Total antioxidant capacity
We will compare total antioxidant capacity between PD patients and HD patients
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Fresenius Medical Care North America
- Responsible party
- Principal investigator, Yong-Lim Kim, Kyungpook National University Hospital
- Investigators
- Yong-Lim Kim, Principal investigator, Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723111
- Sponsor's protocol ID
- knuhhermes
- Acronym
- HERMES
- Status last verified
- Aug 2017
- First submitted
- 2 Nov 2012
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20030521
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin
- ClinicalTrials.gov ID
- NCT01723111
- Acronym / sponsor ID
- HERMES / knuhhermes
- Conditions
- End-stage Renal Disease
- Keywords
- hepcidin, ESA, hemodialysis, peritoneal dialysis, iron metabolism, dialysis modality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Fresenius Medical Care North America
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis | – | –start PD |
| Hemodialysis | – | –start HD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New ESRD patients whose dialysis treatment is expected over 3 months
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ESA (Erythrocyte stimulating agents) dose
Time frame: six months
We will compare ESA dose between PD patients and HD patients
8 secondary outcomes
IV iron treatment (% of patients)
Time frame: six months
Hepcidin level
Time frame: six months
hs-CRP
Time frame: six months
Myeloperoxidase
Time frame: six months
Transfusion rate
Time frame: six months
TNF-a
Time frame: six months
IL-6
Time frame: six months
Total antioxidant capacity
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 20030521Malyszko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-Lim Kim principal investigator
Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Kyungpook National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESA (Erythrocyte stimulating agents) dose (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.