Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

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Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorEast and North Hertfordshire NHS Trust
Government
Locations1 site (Stevenage, Hertfordshire)
StatusRecruiting
StartedJanuary 9, 2025
Main results expectedNovember 1, 2030
Study endsNovember 1, 2030
Registry record updatedJuly 21, 2026
Trial IDNCT07717255 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.