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

13 maj 2016 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

43

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants achieving adequate humoral response to either vaccine
Tidsram: 28 days
as assessed by vaccine-specific serum IgG levels
28 days

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Birmingham

Samarbetspartners

Wellcome Trust
University Hospital Birmingham NHS Foundation Trust

Utredare

  • Huvudutredare: Lorraine Harper, University of Birmingham

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2015

Primärt slutförande (Förväntat)

1 augusti 2017

Studieregistreringsdatum

Först inskickad

25 augusti 2015

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2015

Första postat (Uppskatta)

28 augusti 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 maj 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 maj 2016

Senast verifierad

1 maj 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RG_14-216

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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