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Predicting the Post-dialysis Rebound of β2-microglobulin
Sponsor study identifier
observational
30
1 country
1
Study Start
February 24, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2026
Actual (reported)March 2, 2026
Actual (reported)July 20, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Post-dialysis β2-microglobulin blood concentration (mg/L) at 1 and 2 hours after completion of haemodialysis
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)
The investigator will record small panel of solute clearance markers such as blood urea measured in mmol/L and creatinine umol/L
The study is very short study (Over 2 days)
The Investigator will assess Patient-Reported Outcome Measures (PROMs) related to dialysis quality and dialysis-associated symptom burden, using validated questionnaires
The study is very short study (Over 2 days)
Adult, End Stage Renal Disease established on maintenance haemodialysis for at least 3 months
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
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Participants are those with ESRD undergoing Haemodialysis for at least 3 months.
East and North Hertfordshire NHS Trust
Stevenage, SG1 4AB, United Kingdom
Blood samples obtained from participants, these samples will be centrifuged and then aliquoted in duplicate: 1. One for analysis. 2. One for three years storage. The samples will be analysed for β2-microglobulin. The samples will be sent labelled with study ID number but no personal identifiers to an NHS lab. The sample will be destroyed after data has been analysed. The stored sample will be retained for a maximum of 3 years while data analysis is being completed. After this, stored samples will be destroyed.
Shaza Adam
Lister Hospital, East and North Hertfordshire Teaching NHS Trust
First Submitted
March 2, 2026
First Posted
July 20, 2026
Study Start
February 24, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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