Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Sisli Hamidiye Etfal Training and Research Hospital1 site in 1 country50 target enrollmentSeptember 1, 2018

ConditionsKidney Failure Renal Insufficiency, Chronic Dialysis Related Complication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Failure
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Comparison of pre and post-dialysis of Interleukin (IL) 17-A
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Double blinded, randomized controlled trial evaluating medium cut-off dialyzer compared to high flux dialyzer in ironic hemodialysis patients over a 6 months period with 3 months crossovers.

Registry

clinicaltrials.gov

Start Date

September 1, 2018

End Date

July 1, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Responsible Party

Principal Investigator

Nuri Baris Hasbal

Principal Investigator, MD

Sisli Hamidiye Etfal Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

•patients who are older than 18 years and younger than 65 years
•patient with end-stage renal disease, hemodialysis more than 6 months
•patients under hemodialysis with high-flux dialyzer more than 3 months
•patients willing to participate after given fair and clear information about study

Exclusion Criteria

•patients living with Hepatitis B or C,
•patients with malignancy
•patients under immunosuppressive treatment
•patients with autoimmune diseases such as systemic lupus erythematosus, etc.
•patients with active infections
•patients planned to have a kidney transplantation in 6 months
•patients having vascular access problems
•patients planned to transfer to another center

Outcomes

Primary Outcomes

Comparison of pre and post-dialysis of Interleukin (IL) 17-A

Time Frame: 3 months

Comparison of pre and post-dialysis of IL-17A

Secondary Outcomes

Comparison of pre and post-dialysis of IL-10(3 months)
Comparison of pre and post-dialysis of Interferon (IFN) gama(3 months)
Comparison of pre and post-dialysis necrosis factor (TNF) alpha(3 months)
Comparison of pre and post-dialysis of IL-4(3 months)
Comparison of pre and post-dialysis of Urea(3 months)
Comparison of pre and post-dialysis of creatinine(3 months)
Comparison of pre and post-dialysis of beta2 microglobulin(3 months)
Comparison of pre and post-dialysis of free light chain kappa(3 months)
Comparison of pre and post-dialysis of free light chain lambda(3 months)
Comparison of pre and post-dialysis of myoglobulin(3 months)
Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23(3 months)
Comparison of pre and post-dialysis IL-18 levels(3 months)
Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels(3 months)
Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels(3 months)
Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)(3 months)