Clearance of molecules and inflammatory markers: high-flux vs medium cut-off dialyzers
| ISRCTN | ISRCTN10242184 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10242184 |
| Secondary identifying numbers | ELISIO 110/2022 |
- Submission date
- 26/11/2024
- Registration date
- 16/12/2024
- Last edited
- 03/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Chronic kidney disease (CKD) remains a significant public health challenge, particularly among older adults. Patients on hemodialysis face elevated cardiovascular risks due to the incomplete removal of harmful substances, known as uremic toxins. The ELISIO™ medium cut-off (MCO) dialyzer aims to enhance the removal of these toxins. This study evaluates whether the ELISIO™ dialyzer is at least as effective as, or potentially better than, a standard high-flux dialyzer in removing toxins, reducing inflammation, and minimizing complications.
Who can participate?
Adults currently undergoing regular hemodialysis at least three times per week for three months
What does the study involve?
Participants are randomly assigned to use either the ELISIO™ or a standard dialyzer (NS21) for 2 weeks, then switch to the other dialyzer for another 2 weeks. Blood samples are taken before and after dialysis sessions to measure toxin levels, inflammation markers, and potential albumin loss. Adverse events and side effects are monitored and recorded.
What are the possible benefits and risks of participating?
Participants contribute to advancing dialysis treatment knowledge, potentially improving care for future patients. Risks are minimal and include standard dialysis-related side effects, such as low blood pressure or allergic reactions, observed at similar rates for both dialyzers.
Where is the study run from?
Torrecárdenas University Hospital (Spain)
When is the study starting and how long is it expected to run for?
September 2022 to July 2023
Who is Funding the study?
Nipro (Spain)
Who is the main contact?
Javier Ramírez-Santos, jrs519@inlumine.ual.es
Contact information
Principal Investigator
Nephrology Service. C. Hermandad de Donantes de Sangre, s/n
Almería
04009
Spain
| Phone | +34 (0)950 01 60 00 |
|---|---|
| mpaloma.flores.sspa@juntadeandalucia.es |
Public, Scientific
Almería Health District. Ctra. de Ronda, 226, 2ª Planta
Almería
04009
Spain
 ORCID ID |
0000-0003-3740-5637 |
|---|---|
| Phone | +34 (0)950 18 68 19 |
| jrs519@inlumine.ual.es |
Study information
| Study design | Randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Scientific title | Comparison of molecule clearance and pro-inflammatory markers between high-flux and medium cut-off dialyzers (ELISIO™ 21): a cross-over study |
| Study hypothesis | ELISIO™ is non-inferior to the comparator high-flux dialyzer (NS21). |
| Ethics approval(s) |
Approved 14/09/2022, Torrecárdenas University Hospital Ethics Committee (CEIm) (C/Hermandad Donantes de Sangre s/n, Almería, 04009, Spain; +34 950 016 531; al42_cetico_cht.hto.sspa@juntadeandalucia.es), ref: 110/2022 |
| Condition | End-stage renal disease |
| Intervention | A simple randomization method was used to select participants from the eligible candidates. Group allocation, determined by the dialyzer type, was also assigned through randomization based on each patient’s dialysis shift. Participants are randomly assigned to use either the ELISIO™ or a standard dialyzer (NS21) for 2 weeks, then switch to the other dialyzer for another 2 weeks. Blood samples are taken before and after dialysis sessions to measure toxin levels, inflammation markers, and potential albumin loss. Adverse events and side effects are monitored and recorded. Participants underwent treatment three times per week, either on Monday/Wednesday/Friday or Tuesday/Thursday/Saturday shifts. For the first two weeks, treatment was conducted using the initial dialyzer, followed by an additional two weeks with the second dialyzer. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Bioequivalence |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | MCO ELISIO™ 21HX dialyzer |
| Primary outcome measure | Pre- and post-dialysis levels of creatinine (mg/dL), urea (mg/dL), phosphorus (mg/dL), parathyroid hormone (PTH, pg/mL), and albumin (g/dL) measured using blood sample analysis at the laboratory of Torrecárdenas University Hospital in blood samples collected during the second weekly session of each patient |
| Secondary outcome measures | Pre- and post-dialysis levels of beta-2 microglobulin (mg/L), myoglobin (ng/mL), C-reactive protein (CRP, mg/L), procalcitonin (ng/mL), and interleukin-6 (IL-6, pg/mL) measured using blood sample analysis at the laboratory of Torrecárdenas University Hospital in blood samples collected during the second weekly session of each patient |
| Overall study start date | 01/09/2022 |
| Overall study end date | 30/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 12 |
| Participant inclusion criteria | Being on renal replacement therapy with hemodialysis for at least 3 months prior to inclusion |
| Participant exclusion criteria | 1. Patients with treatment regimens of fewer than three sessions per week 2. Minors 3. Patients hospitalized or deceased during the study |
| Recruitment start date | 01/10/2022 |
| Recruitment end date | 20/10/2022 |
Locations
Countries of recruitment
- Spain
Study participating centre
Almería
04009
Spain
Sponsor information
Industry
C. los Frailes, 94
Daganzo de Arriba, Madrid
28814
Spain
| Phone | +34 (0)918782921 |
|---|---|
| jjavier.gomez@nipro-group.com | |
| Website | https://www.nipro-group.com/ |
"ROR" |
https://ror.org/03creg496 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Nipro Corporation, Nipro Corp., Nipro Medical Corporation, ニプロの, ニプロ株式会社, Nipro Kabushiki-gaisha
- Location
- Japan
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Javier Ramírez-Santos (jrs519@inlumine.ual.es). |
Editorial Notes
03/03/2025: The sponsor email was changed.
29/11/2024: Study's existence confirmed by the Torrecárdenas University Hospital Ethics Committee (CEIm).
