β2M Post-HD Rebound Prediction

NCT07713680 | Recruiting

• 1 other identifier: RD2025-60
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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

Conditions

Renal Disease, End Stage

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• We 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)

• We 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)

Study Arms (1)

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

Interventions

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

End Stage Renal Disease on haemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

East and North Hertfordshire NHS Trust

Stevenage, SG1 4AB, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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. They will be sent labelled with study ID number but no personal identifiers to an NHS lab. These 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.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaza Adam

  Lister Hospital, East and North Hertfordshire Teaching NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaza Adam, Clinical research Fellow

CONTACT

00447365073834; Shaza.adam@nhs.net

Enric Vilar, Consultant Nephrologist and Se

CONTACT

enric.vilar@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: July 20, 2026
• Study Start: February 24, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)