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NCT03836508 Clinical Trial

Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Renal Insufficiency, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03836508
Other study ID # 1909
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date July 1, 2019

Study information
Verified date March 2020
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
Turkey Sisli Hamidiye Etfal Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of pre and post-dialysis of Interleukin (IL) 17-A Comparison of pre and post-dialysis of IL-17A 3 months
Secondary Comparison of pre and post-dialysis of IL-10 Comparison of pre and post-dialysis of IL-10 3 months
Secondary Comparison of pre and post-dialysis of Interferon (IFN) gama Comparison of pre and post-dialysis of IFN gama 3 months
Secondary Comparison of pre and post-dialysis necrosis factor (TNF) alpha Comparison of pre and post-dialysis of TNF alpha 3 months
Secondary Comparison of pre and post-dialysis of IL-4 Comparison of pre and post-dialysis of IL-4 3 months
Secondary Comparison of pre and post-dialysis of Urea Comparison of pre and post-dialysis of Urea 3 months
Secondary Comparison of pre and post-dialysis of creatinine Comparison of pre and post-dialysis of creatinine 3 months
Secondary Comparison of pre and post-dialysis of beta2 microglobulin Comparison of pre and post-dialysis of beta2 microglobulin 3 months
Secondary Comparison of pre and post-dialysis of free light chain kappa Comparison of pre and post-dialysis of free light chain kappa 3 months
Secondary Comparison of pre and post-dialysis of free light chain lambda Comparison of pre and post-dialysis of free light chain lambda 3 months
Secondary Comparison of pre and post-dialysis of myoglobulin Comparison of pre and post-dialysis of myoglobulin 3 months
Secondary Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23 Comparison of pre and post-dialysis of FGF 23 3 months
Secondary Comparison of pre and post-dialysis IL-18 levels Comparison of pre and post-dialysis IL-18 levels 3 months
Secondary Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels Comparison of pre and post-dialysis MCP-1 levels 3 months
Secondary 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
Secondary 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
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