Overview

This trial is active, not recruiting.

Condition end-stage renal disease
Sponsor Kyungpook National University
Collaborator Roche Pharma AG
Start date November 2012
End date February 2016
Trial size 120 participants
Trial identifier NCT01723111, knuhhermes

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
start PD
start HD

Primary Outcomes

Measure
ESA (Erythrocyte stimulating agents) dose
time frame: six months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Prospective, Multicenter, Observational Study to Evaluate the Impact of Peritoneal Dialysis Compared With Hemodialysis on Iron Metabolism and Hepcidin
Principal investigator Yong-Lim Kim
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Kyungpook National University.