An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant
Study Details
Study Description
Brief Summary
The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study.
The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458:
-
Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection
-
Graft survival
-
Allograft function
-
Delayed allograft function
-
Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA)
-
Emergence of de novo donor-specific antibodies
-
Circulating immunoglobulin (Ig) classes (isotypes)
-
Pharmacokinetics (PK) of REGN5459 or REGN5458
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| REGN5459 in study R5459-RT-1944 Received a kidney transplant and were administered REGN5459 in study R5459-RT-1944. |
Other: Noninterventional
No investigational treatment will be given in this noninterventional extension study
|
| REGN5458 in study R5459-RT-1944 Received a kidney transplant and were administered REGN5458 in study R5459-RT-1944. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 R5458 [Up to 12 Months]
- Serum Concentration of R5459 [Up to 12 Months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Received at least 1 dose of treatment with REGN5459 or REGN5458 in study R5459-RT-1944
-
Received, or scheduled to receive 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
Exclusion Criteria:
- There are no exclusion criteria for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Regeneron Pharmaceuticals
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R5459-RT-1956