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OpenTrials
Completed

NCT Number: NCT06710834

Comparing Hemodiafiltration with and Without Hemoadsorption

Goals: The aim of the study is to assess the efficacy and safety of the combination of HDF + HA compared to HDF. To do this, we will evaluate the elimination of a wide range of molecular weight molecules, including small protein-bound solutes.

Design: Prospective, single-center study. Each patient underwent two dialysis sessions with routine dialysis parameters in which HDF or HDF + HA treatment modality will be compared.

Study subjects: 20 patients, stable on a thrice-weekly hemodialysis program, will be included. Local Ethics Committee will approve the study and patients will give informed consent.

Interventions: Prospective collection of two dialysis sessions. The only difference among the sessions in each patient will be add or no sorbent cartridge. One session with FX60 Cordiax, helixone, Fresenius Medical Care in postdilution on-line hemodiafiltration and another session with the same dialyzer plus HA 130 cartridge. The order of these treatment sessions was randomly. Blood samples for analyses were taken for each patient in the same dialysis session of the week.

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Key information

Conditions

Hemodialysis Hemoadsorption Hemodiafiltration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic of Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (age > 18 years)
  • More than 6 months on a dialysis program
  • Stable in a hemodialysis program
  • AV fistula, prosthesis, or tunneled catheter as vascular access
  • No residual diuresis (< 200 ml/day)
  • Not enrolled in a living donor transplant program
  • No immunosuppressive treatment
  • Provide written informed consent

Exclusion criteria

  • Chronic inflammatory diseases
  • Neoplasms
  • Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
  • Dysfunctional AV fistula or catheter
  • Single-needle dialysis
  • Kt/V less than 1.3 or PRU < 70%
  • Scheduled living donor kidney transplant

Treatment and study plan

Hemoadsorption cartridge

Device

HA 130 cartridge

Hemodiafiltration

Device

Postdilutional hemodiafiltration

Primary outcomes

  1. Uremic toxins reduction ratios (RR)

    Time frame: From enrollment to the end of treatment at 4-8 weeks.

    Protein bound uremic toxins: p-cresyl sulfate RR, and indoxyl-sulfate RR. Medium and large molecules: ß2-microglobulin (11,800 Da) RR, myoglobin (17,200 Da) RR, kappa FLC (22,500 Da) RR, prolactin (23,000 Da) RR, α1-microglobulin (33,000 Da) RR, α1-acid glycoprotein (41,000 Da) RR, and lambda FLC (45,000 Da) RR.

Secondary outcomes

  1. Uremic toxins reduction ratios

    Time frame: From enrollment to the end of treatment at 4-8 weeks

    Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Mar 13, 2025

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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