Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05756036 |
| Other study ID # |
291391 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2022 |
| Est. completion date |
March 31, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
Queen Mary University of London |
| Contact |
Ramyangshu Chakraborty, MBBS |
| Phone |
07760781445 |
| Email |
ramyangshu.chakraborty[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To seek an association between Torque Teno Virus DNA titres resulting from under or
over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated
rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of
BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of
circulating NK, B and T lymphocyte subtypes.
Description:
Balancing the adverse effects of over-immunosuppression such as infection and malignancy, to
the risk of rejection, remains the central challenge for day-to-day clinical practice in
transplantation. A quantitative measure of immunocompetence remains elusive, and in the
absence of such markers, immunosuppression drug concentrations and clinical events, such as
organ rejection, infection, malignancy etc. are used as surrogate markers of immunocompetence
to guide therapy. As demonstrated in several studies, the Torque teno virus is widespread
amongst the general population. In theory, if one suppresses the immune system, these viruses
should multiply, resulting in a higher DNA level which can be detected by a simple blood
test. Hence, the DNA level could be used as an indicator for the level of immunosuppression,
along with the available blood tests to measure the level of toxicity of the said drugs.
In this research to be done at the Royal London Hospital, the investigators aim to elucidate
that the Torque teno virus is widely prevalent in an ethnically diverse East London kidney
transplant recipient population by conducting the viral PCR on blood samples already
collected during their routine clinic visits. The population will include all kidney
transplant recipients in a two-year period. The investigators will measure the correlation
between the TTV DNA level and drug concentrations of the immunosuppressive medications which
will elucidate how the DNA levels are affected by different drug concentrations. The
investigators will then measure the correlation between the TTV DNA levels, and the common
adverse outcomes experienced by the transplant recipients, namely, patient death, loss of
transplant organs, transplant rejection, rates of infection, and cancers in transplant
patients by collecting data from patient records. These tests will help understand whether
the Torque teno virus DNA levels can be used as a marker of immunosuppression in the general
population in the UK.
