NCT03836508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

January 20, 2019

Last Update Submit

March 17, 2020

Conditions

Kidney FailureRenal Insufficiency, ChronicDialysis Related Complication

Outcome Measures

Primary Outcomes (1)

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

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

    3 months

Secondary Outcomes (15)

  • Comparison of pre and post-dialysis of IL-10

    3 months

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

    3 months

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

    3 months

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

    3 months

  • Comparison of pre and post-dialysis of Urea

    3 months

  • +10 more secondary outcomes

Study Arms (2)

Medium cut-off

ACTIVE COMPARATOR

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-offDevice: High-Flux

High-flux

ACTIVE COMPARATOR

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-offDevice: High-Flux

Interventions

Medium cut-offDEVICE

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-fluxMedium cut-off
High-FluxDEVICE

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

High-fluxMedium cut-off

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal InsufficiencyRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Sevinc, MD

    Sisli Hamidiye Etfal Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

January 20, 2019

First Posted

February 11, 2019

Study Start

September 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)