HaemodiafiltrationNCT04210154
Comparison of Pre- vs Post-dilution Haemodiafiltration in Children
A study testing Haemodiafiltration in people with Haemodiafiltration, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 4 sites in 4 countries.
Trial summary
Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Haemodiafiltration
- What is being tested?
- Haemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Feb 2021to 30 Nov 2022
- 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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients treated in paediatric dialysis centres between 5-20 years of age
- Receiving maintenance haemodialysis with HD or HDF for the preceding 3 months
- In post-dilution HDF for at least 4 weeks before the start of the study
- Patients with stable vascular access (central line or arteriovenous fistula) and no plan to change access modality for the duration of the study
- Provision for ultrapure water for HDF (defined as containing <0.1 colony forming unit /ml and <0.03 endotoxin unit/ml) documented in the month prior to study start
Who cannot join
- Incident dialysis patients (on HD or HDF for < 3 months)
- Patients with acute infections in the preceding 2 weeks
- Patients with underlying chronic inflammatory disorders (Including vasculitis)
- Single pool Kt/V less than 1.2 in the month prior to the study start.
- Children who have haemoglobin concentrations lower than 10 g/dL
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
France1 site
Division of Pediatric Nephrology Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Lyon, Bron
Germany1 site
Division of Pediatric Nephrology Center for Pediatrics and Adolescent Medicine
Heidelberg
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul
About this study
Official title: Comparison of Pre- and Post-dilution Hemodiafiltration Modalities - Effects on Biocompatibility and Solute Clearance in Children
Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Furthermore, pre-dilution HDF is shown to remove a wider spectrum of uremic toxin compared to post-dilution HDF in adults. The investigators need more data to define the optimum dialysis modality for children.
Read the detailed description
Amendment:
Incorrect date was entered in the study protocol. We apologize for this error, have now corrected.
Amendment Version 2.0 date was mistakenly entered as 20 May 2026 and corrected as 2 May 2025.
"Amendment 1 (Version 2.0; 2 May 2025): (1) Primary outcome changed from β2-microglobulin (β2M) reduction ratio to α1-microglobulin (α1M) serum level and reduction ratio - α1M (33 kDa) is a more sensitive marker of large middle-MW convective clearance; power calculation revised accordingly. The amendment was done before data were analyzed.
---------------------------------------------------------------------------------------------------------------------------- Hypothesis: In children with end stage kidney disease pre-dilution HDF (pre-HDF) achieves improved clearances across a wide molecular weight range compared to post-dilution HDF (post-HDF)."
Plan of Investigation: Prevalent patients on thrice weekly HD or HDF who have a single pool Kt/v>1.2 will be randomized in to either study arm A (pre-HDF, post-HDF) or B (post-HDF, pre-HDF) after a conditioning period on post-HDF. Dialysis prescription will be kept constant during study periods including blood flow, dialysate flow, dialysate content, filter type and size. Pre-dialysis and post-dialysis bloods will be drawn at baseline and at the end of each treatment with either modality. Reduction ratios of small and middle molecular weight toxins and protein bound toxins as well as markers of inflammation and nutrition will be compared between two modalities. Assessment of blood pressure (ambulatory blood pressure monitoring) and patient wellbeing (questionnaire) will be performed at the end of each period.
Children will be recruited from paediatric dialysis units in London, Istanbul Heidelberg and Lyon with extension to other centres to be confirmed.
Outcomes: If the results of this study demonstrate better clearance with pre-dilution HDF compared to post-dilution HDF, this will inform a future long-term outcome study comparing different HDF modalities and will contribute to define optimum dialysis modality for children.
- Conditions
- Haemodiafiltration
- Being tested
- Haemodiafiltration
- Keywords
- Haemodiafiltration, Haemodialysis, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaemodiafiltrationDevice
pre-dilution and post-dilution Haemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| Study Arm A | Experimental | Participants received pre-dilution haemodiafiltration (pre-HDF) for 4 weeks and followed by post-dilution haemodiafiltration (post-HDF) for 4 weeks. Receives: Device: Haemodiafiltration |
| Study Arm B | Experimental | Participants received post-dilution haemodiafiltration (post-HDF) for 4 weeks, followed by pre-dilution haemodiafiltration (pre-HDF) for 4 weeks. Receives: Device: Haemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of middle molecular weight uremic toxins
The outcome measure is the difference in Beta2-microglobulin reduction ratios between pre- and post-dilution HDF treatments. Primary outcome changed from β2-microglobulin (β2M) reduction ratio to α1-microglobulin (α1M) serum level and reduction ratio - α1M (33 kDa) is a more sensitive marker of large middle-MW convective clearance, see detailed description.
Measured: 4 weeks
Secondary outcomes (6)
Removal of low molecular weight
Comparison of urea and creatinine reduction ratios between pre- and post-dilution HDF modalities
Measured: 4 weeks
Removal of protein bound uremic toxins
Comparison of indole acetate and p-cresyl sulphate reduction ratios between pre- and post-dilution HDF modalities
Measured: 4 weeks
Comparison of biocompatibility by using an inflammation markers
Comparison of high sensitive C reactive protein, interleukin 6 and tumor necrosis factor alfa reduction ratios between pre- and post-dilution HDF modalities
Measured: 4 weeks
Removal of nutritional markers
Comparison of Leptin and Ghrelin reduction ratios between pre- and post-dilution HDF modalities
Measured: 4 weeks
Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)
Comparison of systolic and diastolic blood pressures between pre- and post-dilution HDF modalities
Measured: 4 weeks
Child Quality of Life (QoL) questionnaire
Questionnaire including information on post-dialysis recovery time, physical activity, school or college attendance and sleep pattern will be recorded by the patient. Questionnaire will be performed at the end of each period with pre- and post-dilution HDF modality. Scale 1 to 5 - higher scores indicate better outcomes.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Feb 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HaemodiafiltrationStudies 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
- Model description
- 4 weeks of wash-our period with postdilution HDF, then randomized to study arm A (predilution HDF for 4 weeks, then postdilution for 4 weeks) or study arm B (postdilution HDF for 4 weeks, then predilution HDF for 4 weeks).
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Heidelberg University, Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Rukshana Shroff, MD PhD, Study chair, Great Ormond Street Children's Hospital, London, UKSalim Caliskan, Prof Dr, Principal investigator, Istanbul University, Cerrahpasa Medical Faculty, Istanbul, TurkeyNur Canpolat, Assoc Prof, Principal investigator, Istanbul University, Cerrahpasa Medical Faculty, Istanbul, TurkeyAyse Agbas, MD, Principal investigator, University of Health Sciences, Haseki Education and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210154
- Sponsor's protocol ID
- 19BO27
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agbas A, Canpolat N, Ranchin B, Schmitt CP, Flammier S, Scwetlick M, Stronach L, Waters K, Saygili S, Snauwaert E, Eloot S, Paglialonga F, Prodam F, Tini S, Caliskan S, Shroff R. A randomised cross-over trial of pre- and post-filter haemodiafiltration modalities in children on maintenance dialysis - effects on solute removal and blood pressure. Kidney Int. 2026 Sep 16:S0085-2538(26)00739-8. doi: 10.1016/j.kint.2026.07.032. Online ahead of print.
PubMed 42749052
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre- and Post-dilution Hemodiafiltration Modalities - Effects on Biocompatibility and Solute Clearance in Children
- ClinicalTrials.gov ID
- NCT04210154
- Acronym / sponsor ID
- 19BO27
- Conditions
- Haemodiafiltration
- Keywords
- Haemodiafiltration, Haemodialysis, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Istanbul University, Heidelberg University, Hospices Civils de Lyon
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 24 Dec 2019 (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.
Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Furthermore, pre-dilution HDF is shown to remove a wider spectrum of uremic toxin compared to post-dilution HDF in adults. The investigators need more data to define the optimum dialysis modality for children.
Detailed description
Amendment:
Incorrect date was entered in the study protocol. We apologize for this error, have now corrected.
Amendment Version 2.0 date was mistakenly entered as 20 May 2026 and corrected as 2 May 2025.
"Amendment 1 (Version 2.0; 2 May 2025): (1) Primary outcome changed from β2-microglobulin (β2M) reduction ratio to α1-microglobulin (α1M) serum level and reduction ratio - α1M (33 kDa) is a more sensitive marker of large middle-MW convective clearance; power calculation revised accordingly. The amendment was done before data were analyzed.
---------------------------------------------------------------------------------------------------------------------------- Hypothesis: In children with end stage kidney disease pre-dilution HDF (pre-HDF) achieves improved clearances across a wide molecular weight range compared to post-dilution HDF (post-HDF)."
Plan of Investigation: Prevalent patients on thrice weekly HD or HDF who have a single pool Kt/v>1.2 will be randomized in to either study arm A (pre-HDF, post-HDF) or B (post-HDF, pre-HDF) after a conditioning period on post-HDF. Dialysis prescription will be kept constant during study periods including blood flow, dialysate flow, dialysate content, filter type and size. Pre-dialysis and post-dialysis bloods will be drawn at baseline and at the end of each treatment with either modality. Reduction ratios of small and middle molecular weight toxins and protein bound toxins as well as markers of inflammation and nutrition will be compared between two modalities. Assessment of blood pressure (ambulatory blood pressure monitoring) and patient wellbeing (questionnaire) will be performed at the end of each period.
Children will be recruited from paediatric dialysis units in London, Istanbul Heidelberg and Lyon with extension to other centres to be confirmed.
Outcomes: If the results of this study demonstrate better clearance with pre-dilution HDF compared to post-dilution HDF, this will inform a future long-term outcome study comparing different HDF modalities and will contribute to define optimum dialysis modality for children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 4 weeks of wash-our period with postdilution HDF, then randomized to study arm A (predilution HDF for 4 weeks, then postdilution for 4 weeks) or study arm B (postdilution HDF for 4 weeks, then predilution HDF for 4 weeks).
| Arm | Type | Receives |
|---|---|---|
| Study Arm A | Experimental | Device: HaemodiafiltrationParticipants received pre-dilution haemodiafiltration (pre-HDF) for 4 weeks and followed by post-dilution haemodiafiltration (post-HDF) for 4 weeks. |
| Study Arm B | Experimental | Device: HaemodiafiltrationParticipants received post-dilution haemodiafiltration (post-HDF) for 4 weeks, followed by pre-dilution haemodiafiltration (pre-HDF) for 4 weeks. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients treated in paediatric dialysis centres between 5-20 years of age
- Receiving maintenance haemodialysis with HD or HDF for the preceding 3 months
- In post-dilution HDF for at least 4 weeks before the start of the study
- Patients with stable vascular access (central line or arteriovenous fistula) and no plan to change access modality for the duration of the study
- Provision for ultrapure water for HDF (defined as containing <0.1 colony forming unit /ml and <0.03 endotoxin unit/ml) documented in the month prior to study start
Key exclusion criteria (5 listed)
- Incident dialysis patients (on HD or HDF for < 3 months)
- Patients with acute infections in the preceding 2 weeks
- Patients with underlying chronic inflammatory disorders (Including vasculitis)
- Single pool Kt/V less than 1.2 in the month prior to the study start.
- Children who have haemoglobin concentrations lower than 10 g/dL
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 |
|---|---|---|
| Haemodiafiltrationpre-dilution and post-dilution Haemodiafiltration | Device | Study Arm A, Study Arm B |
Primary outcome
Removal of middle molecular weight uremic toxins
Time frame: 4 weeks
The outcome measure is the difference in Beta2-microglobulin reduction ratios between pre- and post-dilution HDF treatments. Primary outcome changed from β2-microglobulin (β2M) reduction ratio to α1-microglobulin (α1M) serum level and reduction ratio - α1M (33 kDa) is a more sensitive marker of large middle-MW convective clearance, see detailed description.
6 secondary outcomes
Removal of low molecular weight
Time frame: 4 weeks
Removal of protein bound uremic toxins
Time frame: 4 weeks
Comparison of biocompatibility by using an inflammation markers
Time frame: 4 weeks
Removal of nutritional markers
Time frame: 4 weeks
Assessment of blood pressure by Ambulatory blood pressure monitoring (ABPM)
Time frame: 4 weeks
Child Quality of Life (QoL) questionnaire
Time frame: 4 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 22 Oct 2026.
- Derived from this study: PubMed 42749052Agbas A, Canpolat N, Ranchin B, Schmitt CP, Flammier S, Scwetlick M, Stronach L, Waters K, Saygili S, Snauwaert E, Eloot S, Paglialonga F, Prodam F, Tini S, Caliskan S, Shroff R. A randomised cross-over trial of pre- and post-filter haemodiafiltration modalities in children on maintenance dialysis - effects on solute removal and blood pressure. Kidney Int. 2026 Sep 16:S0085-2538(26)00739-8. doi: 10.1016/j.kint.2026.07.032. Online ahead of print.
Related trials for Haemodiafiltration
Recruiting
The Microcirculation, Dialysis Modality and Sequestered Salt
End-stage Renal Disease
Recruiting
Analysis of Paediatric Treatments With multiFiltratePRO
Renal Failure, CVVHD
Not yet recruitingObservational study
Clinical Characteristics and In-Hospital Outcomes of Critically Ill Patients Receiving Hemodialysis or Continuous Venovenous Hemodiafiltration in the Emergency Department
Acute Kidney Injury, Kidney Failure, Acute
RecruitingObservational study
Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance
Haemodiafiltration, Haemodialysis
Enrolling by invitation
Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
End-Stage Kidney Disease (ESKD), Chronic Kidney Disease (CKD)
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.
Rukshana Shroff, MD PhD study chair
Great Ormond Street Children's Hospital, London, UK
Salim Caliskan, Prof Dr principal investigator
Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey
Nur Canpolat, Assoc Prof principal investigator
Istanbul University, Cerrahpasa Medical Faculty, Istanbul, Turkey
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haemodiafiltration in people with Haemodiafiltration, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 4 sites in 4 countries.
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 5 inclusion and 5 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, Turkey (Türkiye), United Kingdom. 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?
Removal of middle molecular weight uremic toxins (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210154, which also lists 1 linked publication.
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 22 Oct 2026.