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β2M Post-HD Rebound Prediction

14 juillet 2026 mis à jour par: 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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

30

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Shaza Adam, Clinical research Fellow
  • Numéro de téléphone: 01438287884340 00447365073834
  • E-mail: Shaza.adam@nhs.net

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
End Stage Renal Disease on haemodialysis
Adult, End Stage Renal Disease established on maintenance haemodialysis for at least 3 months
Test diagnostique: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Post-dialysis β2-microglobulin blood concentration (mg/L) at 1 and 2 hours after completion of haemodialysis
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
We will record small panel of solute clearance markers such as blood urea measured in mmol/L and creatinine umol/L
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

East and North Hertfordshire NHS Trust

Les enquêteurs

  • Chercheur principal: Shaza Adam, Lister Hospital, East and North Hertfordshire Teaching NHS Trust

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 février 2026

Achèvement primaire (Estimé)

1 août 2026

Achèvement de l'étude (Estimé)

1 août 2026

Dates d'inscription aux études

Première soumission

2 mars 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

20 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RD2025-60

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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