| NCT ID | NCT07713680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | East and North Hertfordshire NHS Trust |
| Condition | Renal Disease, End Stage |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-02-24 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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.
Eligibility Criteria
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.
Contact & Investigator
Shaza Adam
PRINCIPAL INVESTIGATOR
Lister Hospital, East and North Hertfordshire Teaching NHS Trust
Frequently Asked Questions
Who can join the NCT07713680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Disease, End Stage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07713680 currently recruiting?
Yes, NCT07713680 is actively recruiting participants. Contact the research team at Shaza.adam@nhs.net for enrollment information.
Where is the NCT07713680 trial being conducted?
This trial is being conducted at Stevenage, United Kingdom.
Who is sponsoring the NCT07713680 clinical trial?
NCT07713680 is sponsored by East and North Hertfordshire NHS Trust. The principal investigator is Shaza Adam at Lister Hospital, East and North Hertfordshire Teaching NHS Trust. The trial plans to enroll 30 participants.