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NCT06515899Completed

Association of Middle Molecules Clearance With HDF Volume

Association of Middle Molecules Clearance and Clinical Parameters With Haemodiafiltration Convection Volume

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

HDF is a dialysis technique which involves diffusion and convection. HDF with high convection volume has consistently shown to improve survival in dialysis patients in number of robust RCTs. The precise reason of this survival benefit remains unclear. The investigators hypothesize that this survival benefit with high volume HDF is related to enhanced middle molecule clearance and hemodynamic stability. However, this relationship has not been studied so far. This observational study is aimed to understand the relationship between HDF convection volume with middle molecules (Beta 2-Microglobulin) clearance during HDF. Exploring the relationship of HDF volume with middle molecules clearance has significant clinical ramifications. Only a minority of patients are able to achieve target convection volume. Understanding these relationships can rationalize the HDF prescription from convection volume-based prescription to β2-Microglobulin clearance-based prescription which may be applicable to wider range of patients. The relationship between pre-dialysis β2-Microglobulin levels and RKF offers the prospect of dispensing with pre- and post-dialysis urea and creatinine measurements and interdialytic urine collections, currently necessary for estimating RKF, thus simplifying its estimation. β2-Microglobulin reduction ratio and its component pre and post-dialysis β2-Microglobulin levels could therefore provide a composite estimate of small and middle molecule clearance and RKF.

Status (registry)
Completed
Study type
Observational
Enrollment
342 (actual)
First submitted
16 Feb 2024
Start date
19 Jan 2024
Primary completion date
1 Jul 2025
Lead sponsor
East and North Hertfordshire NHS Trust
NCT number
NCT06515899

What you commit to

  • Study type: Observational
  • Participants enrolled: 342
  • From 19 Jan 2024 to the primary completion date, 1 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age less than 18 years.

Other

  • Inability to give informed consent.
  • Prognosis less than 6 months as assessed by PI

Who the study is looking for

  • Age 18 years or above.
  • Ability to give informed consent.
  • End stage renal failure treated by dialysis for at least 3 months.
  • Established on hemodiafiltration for \>4 weeks.
  • Prognosis more than 6 months as assessed by PI

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
East and North Hertfordshire NHS Trust
Coordinator of this site? Confirm its status
StevenageUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.