Belatacept Dose Reduction for Safety in Low-Allogenic-Risk Kidney Transplant Recipients: A Randomized Non-Inferiority Study

The primary objective is to evaluate the safety of reducing maintenance immunosuppression by half in kidney transplant recipients with low allogenic risk. This is clinically relevant because it assesses whether lower immunosuppressive exposure can be used without compromising transplant safety in a well-matched setting. The secondary objectives are to assess molecular correlates of alloreactivity and to better quantify outcome differences across allogenic risk categories, providing additional information on immunologic risk stratification and its association with clinical outcomes.

The sponsor did not provide the total number of participants. The study population included kidney transplant recipients of both sexes who were adults aged 18 years or older. Participants were selected from patients who had received a deceased donor kidney transplant within the previous three months and were receiving tacrolimus-based immunosuppression. The population was limited to individuals classified as CCRS category 1 or 4, indicating low or high risk, respectively. No information was provided on general health status beyond transplant status, and no lifestyle considerations were reported.

This is a randomized, open-label, assessor-blinded, controlled, non-inferiority clinical trial in adult kidney transplant recipients with a well-matched donor. The study evaluates the safety of half-dose versus standard-dose maintenance immunosuppression and has an overall duration of one year for the intervention phase. Eligible participants are screened at the inclusion visit to confirm criteria such as recent deceased-donor kidney transplantation, age of at least 18 years, tacrolimus-based immunosuppression, and CCRS category 1 or 4. After enrollment, study visits are performed during the one-year intervention phase to assess rejection, donor-specific antibodies, kidney function, donor-derived cell-free DNA, graft loss, infections, and mortality. The end-of-study visit occurs after completion of the intervention phase and is used for final safety and outcome assessment. Participant involvement is expected to last approximately one year. Early termination may occur in the event of graft loss, defined as permanent return to dialysis for more than 3 months or re-transplantation, or for other study discontinuation reasons as determined by the protocol.

Belatacept was administered as NULOJIX 250 mg powder for concentrate for solution for infusion, a solution for infusion for intravenous administration. The study treatment was given at a dose of 6 mg/kg. The source data did not specify the dosing frequency or detailed administration schedule.

No non-experimental comparator, placebo, or standard-of-care treatment was described in the source data. Information on participant compliance monitoring was not provided.

Efficacy will be assessed during the one-year intervention phase by evaluating biopsy-proven rejection defined as Banff grade ≥1A and the occurrence of dnDSAs with MFI >1000. Secondary efficacy assessments will include eGFR levels after the one-year intervention phase, the incidence of ddcfDNA >1% within the one-year intervention phase, and graft loss, defined as permanent return to dialysis for more than 3 months or re-transplantation. These outcomes will be analyzed within the specified intervention period (V5-V17).