Kidney transplant
Conditions
Brief summary
The feasibility of reintroduction of CNIs will be defined by preserved renal function and good tolerance at 6 months post reintroduction (15 months follow-up). Renal function will be defined as preserved if creatinine clearance (according to CKD-EPI) does not decrease by more than 25% after discontinuation of belatacept. Good tolerance of the reinstatement of CNIs will be defined by the absence of complications leading to discontinuation of the treatment.
Detailed description
Longitudinal monitoring of renal function (M0, M3, M6, M9), collection of rejection events., Collection of infectious episodes and neoplasia., Number of care resources consumed in relation to treatments (drugs, hospitalisation, transport, consultations, biological procedures, medical procedures, possible home help) and associated costs over 15 months of follow-up, and collection of cost data from the literature for comparison., Measurement of quality of life scores (generic EQ-5D scale) every 3 months for 15 months and collection of quality of life data from the literature for comparison., Differential analysis (before and after belatacept discontinuation) of cell populations by standardised flow cytometry combined with unbiased analysis., Differential analysis (before and after belatacept discontinuation) of the anti-CMV cellular immune response.
Interventions
Sponsors
Centre Hospitalier Universitaire De Nantes, Centre Hospitalier Universitaire De Nantes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of reintroduction of CNIs will be defined by preserved renal function and good tolerance at 6 months post reintroduction (15 months follow-up). Renal function will be defined as preserved if creatinine clearance (according to CKD-EPI) does not decrease by more than 25% after discontinuation of belatacept. Good tolerance of the reinstatement of CNIs will be defined by the absence of complications leading to discontinuation of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal monitoring of renal function (M0, M3, M6, M9), collection of rejection events., Collection of infectious episodes and neoplasia., Number of care resources consumed in relation to treatments (drugs, hospitalisation, transport, consultations, biological procedures, medical procedures, possible home help) and associated costs over 15 months of follow-up, and collection of cost data from the literature for comparison., Measurement of quality of life scores (generic EQ-5D scale) every 3 months for 15 months and collection of quality of life data from the literature for comparison., Differential analysis (before and after belatacept discontinuation) of cell populations by standardised flow cytometry combined with unbiased analysis., Differential analysis (before and after belatacept discontinuation) of the anti-CMV cellular immune response. | — |
Countries
France
Outcome results
None listed