Investigating the Immune System in chrONIC Kidney Disease. (SONIC)
Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Compared to the general population, people with CKD are known to get more infections and are more likely to have complications from them. Protective measures such as vaccinations for common infections are not as effective in patients with CKD as they are in people with healthy kidneys. The reasons why this happens are not very clear. It is known that with increasing age, the body's immune defences are weakened, but it is not yet clear how different this is in older people with CKD compared to older people with healthy kidneys. Understanding how CKD affects the body's immune defence to new infections is vital in helping to prevent severe consequences from infection and make vaccination more effective for this group of people. This project aims to look at the function of immune cells in CKD patients and people with normal kidney function, together with their responses to clinically recommended vaccinations, including Pneumococcus (common pneumonia organism) and the influenza virus (the flu).
Study participants are invited to receive the clinically recommended seasonal influenza and pneumococcal polysaccharide vaccines during the seasonal influenza vaccination season (September - December), mirroring routine care they would receive in the community. Information on age, gender and pre-existing health problems, together with blood and urine samples will be collected from CKD patients for comparison with healthy volunteers at the following timepoints: day of vaccination, day 7 and 28 and 6 months after vaccination.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
West Midlands
-
Birmingham, West Midlands, Royaume-Uni
- University Hospitals Birmingham NHS Foundation Trust
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
CKD patients - individuals attending local tertiary care nephrology clinics.
Healthy control subjects - individuals accompanying CKD patients to nephrology clinics or individuals invited to participate from Birmingham 1000 Elders Cohort.
La description
Inclusion Criteria:
- any gender
- aged 65 and over
Exclusion Criteria:
- Subjects who have had Pneumovax within last 5 years
- Subjects who have had current season's influenza vaccine
- CKD patients: eGFR less than 15ml/min or greater than 60ml/min, immune mediated cause of kidney disease.
- Healthy control subjects: known kidney disease, eGFR less than 60ml/min
- Subjects with comorbidities that are associated with an immunosuppressed state including, but not limited to, the following: Malignancy diagnosed within last 5 years except non-melanoma skin cancer; Solid organ (including kidney) or bone marrow transplant recipients; Blood borne viral infections: HIV, hepatitis B and C; Autoimmune disease e.g. vasculitis, rheumatoid arthritis; Previous splenectomy or asplenia from any other cause.
- Subjects currently taking any of the following immunosuppressive medications: Systemic corticosteroids e.g. prednisolone/dexamethasone; Chemotherapy agents e.g. cyclophosphamide, methotrexate, azathioprine; Biological therapies e.g. rituximab, infliximab, etanercept - including any administration within preceding 12 months.
- Subjects who have previously had a serious reaction to influenza vaccination, including anaphylaxis and Guillain-Barre Syndrome within 6 weeks of previous influenza vaccination
- Subjects who have a severe egg allergy (contraindication to influenza vaccination)
- Subjects who have previously had a serious reaction to the whole or any components of pneumococcal vaccination
- Subjects who have an active infection and/or are febrile on assessment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Chronic Kidney Disease (CKD) patients
Any gender, aged 65 years and over.
Chronic kidney disease with eGFR between 15 and 60 ml/min.
No immunological cause of kidney disease.
Not immunosuppressed.
To receive both seasonal influenza and pneumococcal polysaccharide vaccines as part of recommended clinical care.
|
Vaccination
|
|
Healthy Control subjects
Any gender, aged 65 years and over.
No known renal disease and eGFR 60ml/min or greater.
Not immunosuppressed.
To receive both seasonal influenza and pneumococcal polysaccharide vaccines as part of recommended clinical care.
|
Vaccination
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of participants achieving adequate humoral response to either vaccine
Délai: 28 days
|
as assessed by vaccine-specific serum IgG levels
|
28 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Délai: 6 months
|
as assessed by vaccine-specific serum IgG levels
|
6 months
|
|
Relationship between eGFR and immune cell subsets following vaccination
Délai: 6 months
|
investigatory outcome - will be assessed using flow cytometric techniques and established biochemical laboratory eGFR testing
|
6 months
|
|
Relationship between eGFR and reported infection rates
Délai: 6 months
|
as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Lorraine Harper, University of Birmingham
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RG_14-216
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .