Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04585607
NCT04585607
Completed
Phase 4

Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia

Gangnam Severance Hospital1 site in 1 country47 target enrollmentOctober 19, 2020
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsChronic Kidney Disease Requiring Chronic Dialysis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Chronic Kidney Disease Requiring Chronic Dialysis
Sponsor
Gangnam Severance Hospital
Enrollment
47
Locations
1
Primary Endpoint
Biomarkers of sarcopenia
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.

Detailed Description

This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.

Registry
clinicaltrials.gov
Start Date
October 19, 2020
End Date
July 7, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyeongcheon Park

Professor

Gangnam Severance Hospital

Eligibility Criteria

Inclusion Criteria

  • •On HD treatment over 6 months before study enrollment
  • •Aged over 18 years
  • •Able to give informed consent

Exclusion Criteria

  • •Hemiplegia or paraplegia state
  • •Planned renal transplant or conversion to peritoneal dialysis within study period
  • •Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
  • •History of monoclonal gammopathy
  • •Life expectancy \<12 months
  • •Pregnancy or breast feeding
  • •Receiving immunosuppressant medication
  • •Inability to complete study assessments

Outcomes

Primary Outcomes

Biomarkers of sarcopenia

Time Frame: Changes in serum level of Myostatin and IGF-1 every 6 months

Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
DIALysis With EXpanded Solute Removal
NCT06660277London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's4,800
Completed
Phase 3
A retrospective comparison of two types of dialysis machine for dialysis patientsEnd stage renal disease (Hemodialysis patients)Urological and Genital DiseasesRenal disease
ISRCTN12403265Renal Therapy Services1,098
Unknown
Not Applicable
Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-HemodiafiltrationChronic Kidney Disease Requiring Chronic Dialysis
NCT03714386Fundación Senefro700
Completed
Not Applicable
Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream InfectionCatheter Related Blood Stream Infection
NCT03054714Ain Shams University798
Enrolling By Invitation
Not Applicable
The Protective Effect of Remote Ischemic Conditioning on Residual Renal Function in Hemodialysis Patients (RIC-HD)End-stage Renal Disease
NCT06275152Yuanjun Yang60