HemodialysisNCT06710834
Comparing Hemodiafiltration with and Without Hemoadsorption
A study testing Hemoadsorption cartridge and Hemodiafiltration in people with Hemodialysis and Hemodiafiltration, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Hemodiafiltration, Hemoadsorption
- What is being tested?
- Hemoadsorption cartridge and Hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone
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.
Read more
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
- Being tested
- Hemoadsorption cartridge, Hemodiafiltration
- Keywords
- Adsorption, Convection, Hemodiafiltration, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoadsorption cartridgeDevice
HA 130 cartridge
HemodiafiltrationDevice
Postdilutional hemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration alone | Active comparator | Not described Receives: Device: Hemodiafiltration |
| Hemodiafiltration plus hemoadsorption | Experimental | Not described Receives: Device: Hemoadsorption cartridge; Device: Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4-8 weeks.
Secondary outcomes (1)
Uremic toxins reduction ratios
Urea RR (60 Da), creatinine RR (113 Da), and albumin (66,000 Da)
Measured: From enrollment to the end of treatment at 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start7 Nov 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Maduell, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710834
- Sponsor's protocol ID
- HCB/2024/0704
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Combining Hemodiafiltration and Hemoadsorption in Comparison to Hemodiafiltration Alone
- ClinicalTrials.gov ID
- NCT06710834
- Acronym / sponsor ID
- HCB/2024/0704
- Conditions
- Hemodialysis, Hemodiafiltration, Hemoadsorption
- Keywords
- Adsorption, Convection, Hemodiafiltration, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodiafiltration alone | Active comparator | Device: Hemodiafiltration |
| Hemodiafiltration plus hemoadsorption | Experimental | Device: Hemoadsorption cartridge, Device: Hemodiafiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- Chronic inflammatory diseases
- Neoplasms
- Immunosuppressive treatment or chronic treatment with anti-inflammatory drugs
- Dysfunctional AV fistula or catheter
- Single-needle dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemoadsorption cartridgeHA 130 cartridge | Device | Hemodiafiltration plus hemoadsorption |
| HemodiafiltrationPostdilutional hemodiafiltration | Device | Hemodiafiltration alone, Hemodiafiltration plus hemoadsorption |
Primary outcome
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.
1 secondary outcome
Uremic toxins reduction ratios
Time frame: From enrollment to the end of treatment at 4-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoadsorption cartridge and Hemodiafiltration in people with Hemodialysis and Hemodiafiltration, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uremic toxins reduction ratios (RR) (time frame: From enrollment to the end of treatment at 4-8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.