Prospective randomized controlled study on the effect of Theranova on quality-of-life outcomes in maintenance dialysis patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003026

Enrollment

Registered

2018-07-25

Start date

2018-03-13

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Fifty stable hemodialysis patients are divided into case group with 25 patients and control group with 25 patients. Case group patients are switched their dialysis membrane to the The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Dialysis treatment more than 3 months 2) Hemodialysis with high-flux dialysis membrane 3) Vascular access for dilaysis via AVF or AVG 4) Adequate dialysis (KT/V >1.2) 5) Age 18 years or older 6) Voluntary enrolled and can answer the questionnaire

Exclusion criteria

Exclusion criteria: 1) Hemodialysis with low-flux dialysis membrane 2) Vascular access for dilaysis via temporary catheter 3) Scheduled KT or admission within 3 months 4) Hematologic malignancy or monoclonal gammopathy 5) Solid organ malignancy 6) Active infection 7) HIV infection 8) Enrolled other clinical trials within 3 months

Design outcomes

Primary

Measure	Time frame
Quality of life questionnaire, pruritis score	—

Secondary

Measure	Time frame
Beta2 microglobulin, complement factor D, homocystein, leptin, hepcidin, erythroferrone, interleukin-6, YKL-40;Hemoglobin level, dosage requirement of erythropoiesis stimulating agents, dosage requirement of iron agent, blood pressure	—

Countries

Korea, Republic of

Contacts

Public ContactJeong-Hoon Lim

Kyungpook National University Hospital

hunph84@naver.com+82-53-200-5559

Outcome results