NCT01723111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

November 2, 2012

Last Update Submit

August 19, 2017

Conditions

End-stage Renal Disease

Keywords

hepcidinESAhemodialysisperitoneal dialysisiron metabolismdialysis modality

Outcome Measures

Primary Outcomes (1)

  • ESA (Erythrocyte stimulating agents) dose

    We will compare ESA dose between PD patients and HD patients

    six months

Secondary Outcomes (8)

  • IV iron treatment (% of patients)

    six months

  • Hepcidin level

    six months

  • hs-CRP

    six months

  • Myeloperoxidase

    six months

  • Transfusion rate

    six months

  • +3 more secondary outcomes

Study Arms (2)

Peritoneal dialysis

start PD

Hemodialysis

start HD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

New ESRD patients whose dialysis treatment is expected over 3 months

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Daegu Fatima Hospital

Daegu, 700-721, South Korea

Location

Dongsan Medical Center

Daegu, 700-721, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Yeungnam University College of Medicine

Daegu, 705-717, South Korea

Location

Related 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.

    PMID: 20030521BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 ml serum will be retained

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yong-Lim Kim

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

KR(4)