| Trial ID: | L0431 |
| Source ID: | NCT05106387
|
| Associated Drug: |
Noninterventional
|
| Title: |
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
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| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease (CKD)
|
| Interventions: |
DRUG: Noninterventional
|
| Outcome Measures: |
Primary: Incidence of Adverse Events, Up to 12 months post-kidney transplant|Incidence of Serious Adverse Events, Up to 12 months post-kidney transplant | Secondary: 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), 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), 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), 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
|
| Sponsor/Collaborators: |
Sponsor: Regeneron Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
20
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2023-10-19
|
| Completion Date: |
2027-12-24
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-11
|
| Locations: |
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|University of California Irvine, Orange, California, 92868, United States|Connie Frank Transplant Center at UCSF, San Francisco, California, 94143, United States|Yale University of Medicine, New Haven, Connecticut, 06520, United States|Comprehensive Transplant Center, Chicago, Illinois, 60611, United States|John Hopkins Hospital, Baltimore, Maryland, 21224, United States|New York University Langone Health, New York, New York, 10016, United States|Penn Transplant Institute, Philadelphia, Pennsylvania, 19104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05106387
|
