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Completed

NCT Number: NCT03836508

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.

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Key information

Conditions

Kidney Failure Chronic Disease Dialysis Related Complication Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium cut-off

Device

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

Device

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

Primary outcomes

  1. Comparison of pre and post-dialysis of Interleukin (IL) 17-A

    Time frame: 3 months

    Comparison of pre and post-dialysis of IL-17A

Secondary outcomes

  1. Comparison of pre and post-dialysis of IL-10

    Time frame: 3 months

    Comparison of pre and post-dialysis of IL-10

  2. Comparison of pre and post-dialysis of Interferon (IFN) gama

    Time frame: 3 months

    Comparison of pre and post-dialysis of IFN gama

  3. Comparison of pre and post-dialysis necrosis factor (TNF) alpha

    Time frame: 3 months

    Comparison of pre and post-dialysis of TNF alpha

  4. Comparison of pre and post-dialysis of IL-4

    Time frame: 3 months

    Comparison of pre and post-dialysis of IL-4

  5. Comparison of pre and post-dialysis of Urea

    Time frame: 3 months

    Comparison of pre and post-dialysis of Urea

  6. Comparison of pre and post-dialysis of creatinine

    Time frame: 3 months

    Comparison of pre and post-dialysis of creatinine

  7. Comparison of pre and post-dialysis of beta2 microglobulin

    Time frame: 3 months

    Comparison of pre and post-dialysis of beta2 microglobulin

  8. Comparison of pre and post-dialysis of free light chain kappa

    Time frame: 3 months

    Comparison of pre and post-dialysis of free light chain kappa

  9. Comparison of pre and post-dialysis of free light chain lambda

    Time frame: 3 months

    Comparison of pre and post-dialysis of free light chain lambda

  10. Comparison of pre and post-dialysis of myoglobulin

    Time frame: 3 months

    Comparison of pre and post-dialysis of myoglobulin

  11. Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23

    Time frame: 3 months

    Comparison of pre and post-dialysis of FGF 23

  12. Comparison of pre and post-dialysis IL-18 levels

    Time frame: 3 months

    Comparison of pre and post-dialysis IL-18 levels

  13. Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels

    Time frame: 3 months

    Comparison of pre and post-dialysis MCP-1 levels

  14. Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels

    Time frame: 3 months

    Comparison of pre and post-dialysis NLRP3 levels

  15. Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)

    Time frame: 3 months

    Comparison of pre and post-dialysis RANTES

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2019
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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