NCT07717255

Brief Summary

The goal of this observational study is to understand the differences in terms of middle molecules clearance and patient outcomes in High (\>23Litres (L)) vs Low (\<23 L) convection volume (CV) Hemodiafiltration (HDF) and to understand the effect of dialysate fluid sodium concentration (137 vs 140 mmol/L) on overhydration volume in patients on HD and HDF.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jan 2025Nov 2030

Study Start

First participant enrolled

January 9, 2025

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

5.8 years

First QC Date

July 2, 2026

Last Update Submit

July 16, 2026

Conditions

HaemodiafiltrationHaemodialysisPatient Reported Outcome MeasurementsNutritionMalnutrition (Calorie)Fluid Balance Outcomes

Keywords

Middle molecules clearance in haemodiafiltraionEffect of dialysis clearance on nutritional statusEffect of dialysis clearance on patient reported outcome measureEffect of dialysate sodium on fluid status

Outcome Measures

Primary Outcomes (2)

  • Effect of high (≥23L) versus low volume HDF (<23L) on middle molecules clearance and on clinical and patients reported outcomes.

    1. Effect of high (≥23L) versus low volume HDF (\<23L) on β2M clearance. 2. Effect of high (≥23L) versus low volume HDF (\<23L) on dialysis related symptom score (measured using IPOS-Renal questionnaire). 3. Effect of high (≥23L) versus low volume HDF (\<23L) on cognitive function (Assessed using PROMIS cognitive function short form). 4. Effect of high (≥23L) versus low volume HDF (\<23L) on malnutrition score (Measured using modified subjective global assessment tool). 5. Effect of high (≥23L) versus low volume HDF (\<23L) on serum phosphate level (mmol/L). 6. Effect of high (≥23L) versus low volume HDF (\<23L) on phosphate binder dose (mg/day). This will be measured cross-sectionally at 0,6 and 12 month time points and longitudinally over time correcting for variables including residual renal function.

    12 months

  • Effect of dialysis fluid sodium concentration of (137 vs 140 mmol/L) on overhydration volume in patients on HD and HDF.

    Effect of dialysis fluid sodium concentration of (137 vs 140 mmol/L) on overhydration volume (measured with Bioimpedance) in patients on HD and HDF. This will be assessed cross-sectionally at 0,6 and 12 months and also longitudinally over time correcting for confounding variables such as RKF.

    12 months

Secondary Outcomes (1)

  • Correlation between middle molecule clearance (β2M clearance) with rate of major adverse cardiovascular events (non-fatal MI, Non-fatal stroke, cardiovascular death) and all cause hospitalizations.

    5 years

Study Arms (4)

HDF group

Particiapants receiving hemodiafiltration

HD group

Participants receiving high flux hemodialysis

Low dialysate sodium group

Participants dialysing with dialysate sodium concentration 137 mmol/L

High dialysate sodium group

Participants dialysing with dialysate sodium concentration 137 mmol/L

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with ESKD receiving hemodialysis accross 5 dialysis units in East and North Hertfordshire NHS Trust , UK.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lister Hospital, East and North Hertfordshire NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Usama Afzal Butt, MBBS, MRCP

    East and North Hertfordshire NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Usama Afzal Butt, MBBS, MRCP (UK)

CONTACT

+441438284340usama.butt1@nhs.net

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 21, 2026

Study Start

January 9, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations

GB(1)