β2M Post-HD Rebound Prediction

July 14, 2026 updated by: East and North Hertfordshire NHS Trust

Predicting the Post-dialysis Rebound of β2-microglobulin

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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shaza Adam, Clinical research Fellow
  • Phone Number: 01438287884340 00447365073834
  • Email: Shaza.adam@nhs.net

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

participants are those with ESRD undergoing Haemodialysis for at least 3 months.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
End Stage Renal Disease on haemodialysis
Adult, End Stage Renal Disease established on maintenance haemodialysis for at least 3 months
Diagnostic test: β2-microglobulin blood concentration in mg/L

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The study is very short study (Over 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The study is very short study (Over 2 days)
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
The study is very short study (Over 2 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East and North Hertfordshire NHS Trust

Investigators

  • Principal Investigator: Shaza Adam, Lister Hospital, East and North Hertfordshire Teaching NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD2025-60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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