Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03836508

Enrollment

Registered

2019-02-11

Start date

2018-09-01

Completion date

2019-07-01

Last updated

2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Related Complication, Kidney Failure, Renal Insufficiency, Chronic

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.

Interventions

DEVICEMedium 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

DEVICEHigh-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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of pre and post-dialysis of Interleukin (IL) 17-A	3 months	Comparison of pre and post-dialysis of IL-17A

Secondary

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026