An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorRegeneron Pharmaceuticals

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Noninterventional

    Drug

    No investigational treatment will be given in this noninterventional extension study

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Vonsetamig in study R5459-RT-19441 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events

Time frame
Up to 12 months post-kidney transplant
2

Incidence of Serious Adverse Events

Time frame
Up to 12 months post-kidney transplant

Secondary outcomes

1

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 frame
Up to 12 Months
2

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)

Time frame
Up to 12 Months
3

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)

Time frame
Up to 12 Months
4

Incidence of graft loss

Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months

Time frame
Up to 12 Months

Other outcomes

Sponsors and contacts

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