About this trial
The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).
No study drug will be given during this study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 [NCT05092347].
Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
Willing and able to comply with clinic visits and study-related procedures
Provide informed consent signed by study patient or legally acceptable representative
Disqualifiers
None
Trial population
This study is designed to collect safety and outcomes data in patients aged 18 through 70 years who receive a kidney transplant and were administered vosentamig in study R5459-RT-1944 \[NCT05092347\].
Trial design
Cohort
Prospective
Treatments tested in this trial
Noninterventional
DrugNo investigational treatment will be given in this noninterventional extension study
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Adverse Events
Incidence of Serious Adverse Events
Secondary outcomes
Incidence of biopsy-proven kidney allograft rejection
Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification: * Active antibody-mediated rejection (AMR) (Category 2) * Chronic active AMR (Category 2) * Acute t-cell-mediated rejection (TCMR) (Category 4) * Chronic active TCMR (Category 4)
Time to diagnosis of biopsy-proven kidney allograft rejection
Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification: * Active antibody-mediated rejection (AMR) (Category 2) * Chronic active AMR (Category 2) * Acute t-cell-mediated rejection (TCMR) (Category 4) * Chronic active TCMR (Category 4)
Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection
Responsiveness to therapy by 12 months of each of the following types of biopsy-proven kidney allograft rejection according to Banff classification: * Active antibody-mediated rejection (AMR) (Category 2) * Chronic active AMR (Category 2) * Acute t-cell-mediated rejection (TCMR) (Category 4) * Chronic active TCMR (Category 4)
Incidence of graft loss
Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months
Sponsors and contacts
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