Clinical trial NCT03836508: Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
Official title: Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure
Renal Insufficiency, Chronic
Dialysis Related Complication
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Comparison of pre and post-dialysis of Interleukin (IL) 17-A
timeFrame: 3 months
Secondary outcomes:
measure: Comparison of pre and post-dialysis of IL-10
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of Interferon (IFN) gama
timeFrame: 3 months
measure: Comparison of pre and post-dialysis necrosis factor (TNF) alpha
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of IL-4
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of Urea
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of creatinine
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of beta2 microglobulin
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of free light chain kappa
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of free light chain lambda
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of myoglobulin
timeFrame: 3 months
measure: Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23
timeFrame: 3 months
measure: Comparison of pre and post-dialysis IL-18 levels
timeFrame: 3 months
measure: Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels
timeFrame: 3 months
measure: Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels
timeFrame: 3 months
measure: Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Mustafa Sevinc, MD
role: PRINCIPAL_INVESTIGATOR
References: