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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonsetamig in study R5459-RT-1944 | Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 [NCT05092347]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninterventional | Drug | No investigational treatment will be given in this noninterventional extension study |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Up to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
1.There are no exclusion criteria for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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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].
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States | |
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| 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:
| 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:
| Up to 12 Months |
| Incidence of graft loss | Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months | Up to 12 Months |
| Time to graft loss | Time to graft loss (defined as becoming dialysis-dependent) by 12 months | Up to 12 Months |
| Change in estimated glomerular filtration rate (eGFR) over time | Up to 12 Months |
| Incidence of delayed graft function | Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant) | 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 | 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 | Up to 12 months |
| Change in Calculated panel-reactive antibody (cPRA) over time | 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 | 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 | 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 | Up to 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 | Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM) | Up to 12 Months |
| Serum Concentration of vonsetamig | Up to 12 Months |
| University of California Irvine |
| Recruiting |
| Orange |
| California |
| 92868 |
| United States |
| Connie Frank Transplant Center at UCSF | Recruiting | San Francisco | California | 94143 | United States |
| Yale University of Medicine | Completed | New Haven | Connecticut | 06520 | United States |
| Comprehensive Transplant Center | Recruiting | Chicago | Illinois | 60611 | United States |
| John Hopkins Hospital | Recruiting | Baltimore | Maryland | 21224 | United States |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| New York University Langone Health | Completed | New York | New York | 10016 | United States |
| Penn Transplant Institute | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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