Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Conditions
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Kidney Failure, Renal Insufficiency, Chronic, Dialysis Related Complication

Intervention / Treatment
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* Device: Medium cut-off
* Device: High-Flux


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medium cut-off<br>Medium cut-off dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using high-flux dialyzers. | Device: Medium cut-off<br>* All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min<br>Device: High-Flux<br>* All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min<br>|
| Active Comparator: High-flux<br>High-flux dialyzers will be used in this group containing 26 randomized patients for three months. At the end of the third month with crossover, this groups of patients will start using medium cut-off dialyzers. | Device: Medium cut-off<br>* All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min<br>Device: High-Flux<br>* All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp. Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pre and post-dialysis of Interleukin (IL) 17-A | Comparison of pre and post-dialysis of IL-17A | 3 months | 

Secondary Outcome Measures

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