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.
Study Type
OBSERVATIONAL
Enrollment
20
No investigational treatment will be given in this noninterventional extension study
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California Irvine
Orange, California, United States
RECRUITINGIncidence of Adverse Events
Time frame: Up to 12 months post-kidney transplant
Incidence of Serious Adverse Events
Time frame: Up to 12 months post-kidney transplant
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
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
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
Incidence of graft loss
Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months
Time frame: Up to 12 Months
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Connie Frank Transplant Center at UCSF
San Francisco, California, United States
Yale University of Medicine
New Haven, Connecticut, United States
RECRUITINGComprehensive Transplant Center
Chicago, Illinois, United States
RECRUITINGJohn Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGNew York University Langone Health
New York, New York, United States
RECRUITINGPenn Transplant Institute
Philadelphia, Pennsylvania, United States
RECRUITINGTime to graft loss
Time to graft loss (defined as becoming dialysis-dependent) by 12 months
Time frame: Up to 12 Months
Change in estimated glomerular filtration rate (eGFR) over time
Time frame: Up to 12 Months
Incidence of delayed graft function
Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant)
Time frame: Up to Day 7
Percent Change in anti-HLA alloantibodies
Percent Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection
Time frame: Up to 12 months
Mean Fluorescence Intensity Change in anti-HLA alloantibodies
Mean Fluorescence Intensity (MFI) Change in anti-HLA alloantibodies (SAB assay) compared with pretransplant levels at 2, 3, 6, and 12 months, and at the time of suspected clinical episodes of allograft rejection
Time frame: Up to 12 months
Change in Calculated panel-reactive antibody (cPRA) over time
Time frame: Up to 12 Months
Percent Change in donor-specific anti-HLA alloantibodies
Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels
Time frame: Up to 12 Months
Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies
Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels
Time frame: Up to 12 Months
Incidence of de novo anti-HLA alloantibody development
Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months
Time frame: Up to 12 Months
Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time
Time frame: Up to 12 Months
Percent change from baseline of circulating serum concentrations of Ig classes
Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM)
Time frame: Up to 12 Months
Serum Concentration of vonsetamig
Time frame: Up to 12 Months