Adequacy of Middle Molecules Clearance in Haemodiafiltration and its Relation to Patient Outcomes
Official title: Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance
Run by East and North Hertfordshire NHS Trust · NCT07717255 · Data updated 2026-11-12
This study looks at whether higher convective volumes in haemodiafiltration and different dialysate sodium levels affect toxin clearance, patient-reported outcomes, and nutritional status in adults with end-stage kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Locations | 1 site (Stevenage, Hertfordshire) |
| Status | Recruiting |
| Started | January 9, 2025 |
| Main results expected | November 1, 2030 |
| Study ends | November 1, 2030 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT07717255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with end-stage kidney disease on haemodialysis for at least 3 months, able to consent, and with a prognosis greater than 6 months.
✕Probably not a fit
Patients whose dialysis dose or dialysate composition does not significantly affect middle-molecule clearance or symptoms may see no measurable benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares high (>23 L) versus low (<23 L) convection volumes in haemodiafiltration and examines how dialysate sodium concentration (137 vs 140 mmol/L) influences overhydration in patients receiving hemodialysis or haemofiltration. The goal is to see if better removal of middle molecules correlates with improved patient-reported symptoms and nutritional status, beyond traditional small-molecule metrics like Kt/V. The analysis will consider quality of life, hydration status, and nutrition, acknowledging that dialysis effectiveness today includes multiple factors beyond urea clearance. Participants include adults with end-stage kidney disease on dialysis for at least 3 months and a projected prognosis over 6 months.
Why it matters
Potential benefit: If successful, the findings could guide dialysis prescriptions to optimize middle-molecule clearance and hydration, potentially improving patient well-being and nutritional status.
How similar studies have gone: Previous work suggests middle-molecule clearance may impact symptoms, but clear links to patient-reported outcomes and nutrition in routine practice remain to be proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or above. * Ability to give informed consent. * End stage kidney disease (ESKD) treated by haemodialysis for at least 3 months. * Prognosis \> 6 months as assessed by principal investigator (PI)
Where it's running
-
Lister Hospital, East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Usama Afzal Butt, MBBS, MRCP — East and North Hertfordshire NHS Trust
- Study coordinator: Usama Afzal Butt, MBBS, MRCP (UK)
- Email: usama.butt1@nhs.net
- Phone: +441438284340
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.