OPTimising IMmunosuppression in older Adult kidney transpLants

  • Research type

    Research Study

  • Full title

    The OPTIMAL feasibility trial: OPTimising IMmunosuppression for older Adult kidney transpLant recipients

  • IRAS ID

    318634

  • Contact name

    Pippa Bailey

  • Contact email

    pippa.bailey@bristol.ac.uk

  • Sponsor organisation

    North Bristol NHS Trust

  • ISRCTN Number

    ISRCTN14416006

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    Every day in the UK, 10 people over 65 years develop kidney failure. More of these older adults are receiving kidney transplants. People with transplants need to take tablets to prevent their bodies from rejecting the transplant(‘immunosuppression’).
    The immune system becomes less effective in later life, meaning lower doses of immunosuppression tablets may be enough to stop transplant rejection. The amount of immunosuppression medication given to older transplant recipients is currently based on research in young people. Immunosuppression tablets affect older adults differently, causing more infections, cancers and side-effects which prevent people from living well. Lower doses of immunosuppressives may prevent these problems.
    However, less immunosuppression could mean someone is more likely to need treatment for rejection. Older adults could find the side-effects of treatment for rejection more severe than younger adults. It may be that older recipients prefer to live with the side-effects of standard immunosuppressive doses to avoid rejection.

    We do not know what the right level of immunosuppression is for older transplant recipients. There are no national guidelines. Older people cared for at different UK kidney units receive different treatments.

    This research aims to investigate whether lower immunosuppression drug doses are better for older transplant recipients than standard doses.

    We will undertake a ‘test’ trial in new transplant recipients aged 65 and older. We will give half the people in the trial higher doses of Mycophenolate mofetil (MMF) (1.5g each day) and half the people lower doses (1g each day). This ‘test’ trial will determine whether it would be possible to do the same trial on a larger scale.
    If this ‘test’ trial shows a larger trial is possible, we will do a larger UK-wide study afterwards. The study results will help us make sure that older transplant recipients get the drug treatment that enables them to live as long and as
    well as possible.

  • REC name

    Wales REC 2

  • REC reference

    24/WA/0343

  • Date of REC Opinion

    19 Nov 2024

  • REC opinion

    Favourable Opinion