Polyomavirus Infections Clinical Trial
Official title:
Prospective Randomized Study to Characterize Risk Factors of Polyomavirus-related Transplant Nephropathy and the Impact of Three Immunosuppressive Regimens on Nephropathy Incidence
The aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (PVN) including the impact of three immunosuppressive regimens.
Polyomavirus nephropathy (PVN) is an emerging cause of renal transplant loss. Until now the
risk factors of PVN are poorly understood. Tacrolimus (Tacr) and mycophenolate mofetil (MMF)
are thought to be associated with a higher risk of developing PVN. However, the way in which
Tacr or MMF might enhance the susceptibility for PVN remains largely unknown. In this
prospective study we will analyze whether differences in immune-reactivity patterns (Th1,
Th2, B cell and monocyte responses, sCD30, immunoregulatory antibodies) of renal transplant
patients induced by different immunosuppressive regimens (cyclosporine A [CsA]/MMF,
Tacr/MMF, Tacr/MMF with conversion to Tacr/Everolimus [ERL]) or by cytokine promoter gene
polymorphisms may account for the different risks of developing PVN.
Comparison(s): renal transplant recipients stratified according to their relative
immunological risk (group 1: low risk (primary recipients without pre-immunization [PRA <
5%]); group 2: moderate risk (group 2a: primary recipients with low pre-immunization [PRA
6-20%]; group 2b: re-transplanted patients); group 3: very high risk (re-transplanted
patients with a history of vascular rejection or recipients of a first graft with high
pre-immunization [PRA > 20%]) randomized to be treated with one of three immunosuppressive
regimens (CsA/MMF, Tacr/MMF, Tacr/MMF with subsequent conversion to Tacr/ERL).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05224583 -
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant
|