Chronic Kidney Disease (CKD)
Conditions
Keywords
Kidney Transplant
Brief summary
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.
Interventions
No investigational treatment will be given in this noninterventional extension study
Sponsors
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \[NCT05092347\]. 2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide informed consent signed by study patient or legally acceptable representative
Exclusion criteria
1.There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | Up to 12 months post-kidney transplant |
| Incidence of Serious Adverse Events | Up to 12 months post-kidney transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of biopsy-proven kidney allograft rejection | Up to 12 Months | 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 | Up to 12 Months | 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 | Up to 12 Months | 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 | Up to 12 Months | Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months |
| Time to graft loss | Up to 12 Months | Time to graft loss (defined as becoming dialysis-dependent) by 12 months |
| Change in estimated glomerular filtration rate (eGFR) over time | Up to 12 Months | — |
| Incidence of delayed graft function | Up to Day 7 | Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant) |
| Percent Change in anti-HLA alloantibodies | Up to 12 months | 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 |
| Mean Fluorescence Intensity Change in anti-HLA alloantibodies | Up to 12 months | 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 |
| Change in Calculated panel-reactive antibody (cPRA) over time | Up to 12 Months | — |
| Percent Change in donor-specific anti-HLA alloantibodies | Up to 12 Months | Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels |
| Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies | Up to 12 Months | Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels |
| Incidence of de novo anti-HLA alloantibody development | Up to 12 Months | Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months |
| Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time | Up to 12 Months | — |
| Percent change from baseline of circulating serum concentrations of Ig classes | Up to 12 Months | Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM) |
| Serum Concentration of vonsetamig | Up to 12 Months | — |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed