Comparing Hemodiafiltration with and Without Hemoadsorption

NCT06710834 | Completed

• 1 other identifier: HCB/2024/0704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis; Hemodiafiltration; Hemoadsorption

Keywords

Adsorption; Convection; Hemodiafiltration; Efficacy

Outcome Measures

Primary Outcomes (1)

• Uremic toxins reduction ratios (RR)

  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.

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

Secondary Outcomes (1)

• Uremic toxins reduction ratios

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

Study Arms (2)

Hemodiafiltration alone

ACTIVE COMPARATOR

Device: Hemodiafiltration

Hemodiafiltration plus hemoadsorption

EXPERIMENTAL

Device: Hemoadsorption cartridge; Device: Hemodiafiltration

Interventions

Hemoadsorption cartridge DEVICE

HA 130 cartridge

Hemodiafiltration plus hemoadsorption

Hemodiafiltration DEVICE

Postdilutional hemodiafiltration

Hemodiafiltration alone; Hemodiafiltration plus hemoadsorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic of Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Hemodiafiltration

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dialysis Section

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: November 7, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)