An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
- Conditions
- Chronic Kidney Disease (CKD)
- Interventions
- Drug: Noninterventional
- Registration Number
- NCT05106387
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
1.There are no exclusion criteria for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vonsetamig in study R5459-RT-1944 Noninterventional Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 \[NCT05092347\].
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events Up to 12 months post-kidney transplant Incidence of Serious Adverse Events Up to 12 months post-kidney transplant
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Connie Frank Transplant Center at UCSF
🇺🇸San Francisco, California, United States
Yale University of Medicine
🇺🇸New Haven, Connecticut, United States
Comprehensive Transplant Center
🇺🇸Chicago, Illinois, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
New York University Langone Health
🇺🇸New York, New York, United States
Penn Transplant Institute
🇺🇸Philadelphia, Pennsylvania, United States
Cedars-Sinai Medical Center🇺🇸Los Angeles, California, United States