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Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Primary Purpose

Kidney Failure, Renal Insufficiency, Chronic, Dialysis Related Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Medium cut-off
High-Flux
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sisli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medium cut-off

High-flux

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 20, 2019
Last Updated
March 17, 2020
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03836508
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Renal Insufficiency, Chronic, Dialysis Related Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medium cut-off
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-flux
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medium cut-off
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
High-Flux
Intervention Description
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 Outcome Measure Information:
Title
Comparison of pre and post-dialysis of Interleukin (IL) 17-A
Description
Comparison of pre and post-dialysis of IL-17A
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comparison of pre and post-dialysis of IL-10
Description
Comparison of pre and post-dialysis of IL-10
Time Frame
3 months
Title
Comparison of pre and post-dialysis of Interferon (IFN) gama
Description
Comparison of pre and post-dialysis of IFN gama
Time Frame
3 months
Title
Comparison of pre and post-dialysis necrosis factor (TNF) alpha
Description
Comparison of pre and post-dialysis of TNF alpha
Time Frame
3 months
Title
Comparison of pre and post-dialysis of IL-4
Description
Comparison of pre and post-dialysis of IL-4
Time Frame
3 months
Title
Comparison of pre and post-dialysis of Urea
Description
Comparison of pre and post-dialysis of Urea
Time Frame
3 months
Title
Comparison of pre and post-dialysis of creatinine
Description
Comparison of pre and post-dialysis of creatinine
Time Frame
3 months
Title
Comparison of pre and post-dialysis of beta2 microglobulin
Description
Comparison of pre and post-dialysis of beta2 microglobulin
Time Frame
3 months
Title
Comparison of pre and post-dialysis of free light chain kappa
Description
Comparison of pre and post-dialysis of free light chain kappa
Time Frame
3 months
Title
Comparison of pre and post-dialysis of free light chain lambda
Description
Comparison of pre and post-dialysis of free light chain lambda
Time Frame
3 months
Title
Comparison of pre and post-dialysis of myoglobulin
Description
Comparison of pre and post-dialysis of myoglobulin
Time Frame
3 months
Title
Comparison of pre and post-dialysis of fibroblast growth factor (FGF) 23
Description
Comparison of pre and post-dialysis of FGF 23
Time Frame
3 months
Title
Comparison of pre and post-dialysis IL-18 levels
Description
Comparison of pre and post-dialysis IL-18 levels
Time Frame
3 months
Title
Comparison of pre and post-dialysis monocyte chemoattractant protein (MCP)-1 levels
Description
Comparison of pre and post-dialysis MCP-1 levels
Time Frame
3 months
Title
Comparison of pre and post-dialysis NACHT, LRR and PYD domains-containing protein3 (NLRP3) levels
Description
Comparison of pre and post-dialysis NLRP3 levels
Time Frame
3 months
Title
Comparison of pre and post-dialysis regulated on activation, normal T cell expressed and secreted (RANTES)
Description
Comparison of pre and post-dialysis RANTES
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Sevinc, MD
Organizational Affiliation
Sisli Hamidiye Etfal Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sisli Hamidiye Etfal Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

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