Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Not Applicable

Completed

• Conditions: Kidney Failure; Renal Insufficiency, Chronic; Dialysis Related Complication

• Registration Number: NCT03836508
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparison of pre and post-dialysis of Interleukin (IL) 17-A	3 months	Comparison of pre and post-dialysis of IL-17A

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sisli Hamidiye Etfal Training and Research Hospital; 🇹🇷 Istanbul, Turkey