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Investigating the Immune System in chrONIC Kidney Disease. (SONIC)

13. mai 2016 oppdatert av: University of Birmingham

Investigating the Immune System in chrONIC Kidney Disease - the SONIC Study.

This study will investigate the function of the immune system in people with chronic kidney disease (CKD) compared to people with normal kidneys. The investigators will use standard vaccines - the seasonal flu vaccine and pneumococcal polysaccharide (Pneumovax) vaccine - to examine how the immune system responds to challenge. All subjects will receive these recommended vaccines as part of routine care. Blood and urine samples will be collected and tested at different time points to look at how the immune response develops to these vaccines and if there are any differences between people with CKD and those without. This will help us understand how CKD affects the function of the immune system.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

43

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • West Midlands
      • Birmingham, West Midlands, Storbritannia
        • University Hospitals Birmingham NHS Foundation Trust

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Biologisk: Seasonal influenza and pneumococcal polysaccharide vaccines
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.
Biologisk: Seasonal influenza and pneumococcal polysaccharide vaccines
Vaccination

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants achieving adequate humoral response to either vaccine
Tidsramme: 28 days
as assessed by vaccine-specific serum IgG levels
28 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants who maintain protective antibody titres to either vaccine at 6 months after vaccination
Tidsramme: 6 months
as assessed by vaccine-specific serum IgG levels
6 months
Relationship between eGFR and immune cell subsets following vaccination
Tidsramme: 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
Tidsramme: 6 months
as assessed using established biochemical laboratory eGFR testing and participant reported infection-related events
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Birmingham

Samarbeidspartnere

Wellcome Trust
University Hospital Birmingham NHS Foundation Trust

Etterforskere

  • Hovedetterforsker: Lorraine Harper, University of Birmingham

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2015

Primær fullføring (Forventet)

1. august 2017

Datoer for studieregistrering

Først innsendt

25. august 2015

Først innsendt som oppfylte QC-kriteriene

27. august 2015

Først lagt ut (Anslag)

28. august 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RG_14-216

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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