Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Kidney Failure; Dialysis Related Complication
• Intervention / Treatment: Device: Medium cut-off; Device: High-Flux

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medium cut-off; 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; 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; Device: High-Flux; 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
Active Comparator: High-flux; 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; 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; Device: High-Flux; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 1909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No