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NCT Number: NCT07713680

β2M Post-HD Rebound Prediction

β2-Microglobulin is small 11.8 kDa protein presents on the surface of all nucleated cell in the human body, it forms part of the non-variable chain of Major Histocompatibility Complex class I. β2-Microglobulin production is constant and it is continuously released into the bloodstream. Its production increases during active infections, inflammation or blood cancers. The Kidneys are the main route of its elimination. It accumulates in patients with kidney disease and levels can rise significantly in patients with end-stage renal failure. Studies have shown that its accumulation in dialysis patients contributes to dialysis-related amyloidosis.

Haemodialysis is a significant contributor to removal of β2-microglobulin in those on dialysis. It removes β2-microglobulin from the blood rather than directly from tissues. Blood levels fall during dialysis. However, after haemodialysis, β2-microglobulin gradually moves from tissues into the bloodstream until equilibrium is reached (post-dialysis rebound). Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude. β2-Microglobulin is increasingly recognized as an important marker of middle-molecule solute clearance.

The investigators plan to recruit thirty haemodialysis patients. During two dialysis sessions blood samples will be taken to measure β2-microglobulin. During the first session, samples will be taken pre-dialysis and at intervals during the session. Post-dialysis samples will be taken at 1 and 2 hour time points. The investigators will perform a physical examination, fluid/nutrition assessment. Dialysis prescription and routine monthly blood and urine results will also be recorded, and patients will be asked to complete questionnaires about dialysis symptoms, fatigue and post-dialysis recovery time. At the start of the next dialysis, one final β2-microglobulin sample will be taken.

β2-microglobulin removal may be a useful marker of dialysis quality. The investigators aim to develop a predictive model to estimate the equilibrated β2-microglobulin to allow its dialysis clearance to be accurately assessed.

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Key information

Conditions

Renal Disease, End Stage Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East and North Hertfordshire NHS Trust

Stevenage, SG1 4AB, United Kingdom

Location status: Recruiting

Location contact

Toral Odedra, Research Sponsorship Coordinat

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or above.
  • Ability to give informed consent.
  • End Stage Renal Disease established on maintenance haemodialysis for at least 3 months

Exclusion criteria

  • Inability to give informed consent.
  • Acute infection in last 2 weeks.

Treatment and study plan

β2-microglobulin blood concentration in mg/L

Diagnostic Test

Blood samples for β2-microglobulin measurement will be collected by study investigator across two haemodialysis sessions. During the first study visit (HD1), blood samples will be obtained pre-dialysis (0%), at 20%, 40%, 60%, and 80% of the prescribed dialysis duration, at the end of dialysis (100%), and at 1 hour and 2 hours following completion of dialysis. During the second study visit (HD2), a single pre-dialysis β2-microglobulin sample will be collected at the start of the participant's next routine haemodialysis session, which is second and last study visit.

All study samples will be used to measure β2-Microglobulin concentration in mg/L

Primary outcomes

  1. Post-dialysis β2-microglobulin blood concentration (mg/L) at 1 and 2 hours after completion of haemodialysis

    Time frame: The study is very short study (Over 2 days)

    β2-microglobulin blood samples will be collected at time points including pre-dialysis (0%), at 20%, 40%, 60%, 80%, and 100% of the dialysis session, as well as at 1 hour and 2 hours post-dialysis. An additional pre-dialysis sample will be obtained before the next routine haemodialysis session (approximately 48 hours later).

    The primary outcome measure will be the β2-microglobulin concentration (mg/L) at 1 and 2 hours post-dialysis, which will serve as the dependent variable in regression-based and software-assisted modelling. These models will be used to develop an algorithm capable of accurately predicting the equilibrated post-dialysis β2-microglobulin concentration from measurements obtained during the dialysis session.

Secondary outcomes

  1. We will record small panel of solute clearance markers such as blood urea measured in mmol/L and creatinine umol/L

    Time frame: The study is very short study (Over 2 days)

    This is recorded from the standard of care blood tests assessing monthly dialysis adequacy. Derived from routine monthly dialysis adequacy testing done at same time period of the study sample collection.

  2. We will assess Patient-Reported Outcome Measures (PROMs) related to dialysis quality and dialysis-associated symptom burden, using validated questionnaires

    Time frame: The study is very short study (Over 2 days)

    The following validated Questionnaires will be used to assess Patient Reported Outcome Measure (PROM): SONG-HD Fatigue, Recovery time and IPOS Renal questionnaires .

    The questionnaire burden was discussed at the Patients and Public Involvement Group meeting within the trust and considered in study design. The questionnaires were considered relevant and the burden on patients was judged to be acceptable and not a major barrier to participation. To minimise the participants being overwhelmed with questionnaires, we will offer them flexibility of completing the questionnaires during and or after first study visit (either on dialysis or at home). They may also receive support from family, friend and or medical staff team to help filling these questionnaires as needed. It is anticipated that each questionnaire will take approximately 5 minutes to complete. We expect most patients will complete this during their dialysis treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Enric Vilar, Consultant Nephrologist and Se

CONTACT

[email protected]

Shaza Adam, Clinical research Fellow

CONTACT

[email protected]

00447365073834 ext. 01438287884340

Sponsors and collaborators

Lead sponsor

East and North Hertfordshire NHS Trust

Other Gov

Registry information

Official study title

Predicting the Post-dialysis Rebound of β2-microglobulin

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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