NCT_ID: NCT05106387
Clinical Trial Link
Brief Summaries
| Sequence: | 30705290 |
| Description | 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 |
Studies
| Study First Submitted Date | 2021-10-22 |
| Study First Posted Date | 2021-11-03 |
| Last Update Posted Date | 2023-05-17 |
| Start Month Year | June 15, 2023 |
| Primary Completion Month Year | March 8, 2025 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-17 |
Facilities
| Sequence: | 199621671 | Sequence: | 199621672 | Sequence: | 199621673 | Sequence: | 199621674 |
| Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
| Name | Cedars-Sinai Medical Center | Name | Yale University School of Medicine Transplant Surgery | Name | New York University Langone Health – Transplant Institute | Name | University of Pennsylvania-Penn Transplant Institute |
| City | Los Angeles | City | New Haven | City | New York | City | Philadelphia |
| State | California | State | Connecticut | State | New York | State | Pennsylvania |
| Zip | 90048 | Zip | 06519 | Zip | 10016 | Zip | 19104 |
| Country | United States | Country | United States | Country | United States | Country | United States |
Conditions
| Sequence: | 52066108 |
| Name | Chronic Kidney Disease (CKD) |
| Downcase Name | chronic kidney disease (ckd) |
Id Information
| Sequence: | 40075181 |
| Id Source | org_study_id |
| Id Value | R5459-RT-1956 |
Countries
| Sequence: | 42473009 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55478015 | Sequence: | 55478016 |
| Title | REGN5459 in study R5459-RT-1944 | Title | REGN5458 in study R5459-RT-1944 |
| Description | Received a kidney transplant and were administered REGN5459 in study R5459-RT-1944. | Description | Received a kidney transplant and were administered REGN5458 in study R5459-RT-1944. |
Interventions
| Sequence: | 52378569 |
| Intervention Type | Other |
| Name | Noninterventional |
| Description | No investigational treatment will be given in this noninterventional extension study |
Keywords
| Sequence: | 79695732 |
| Name | kidney transplant |
| Downcase Name | kidney transplant |
Design Outcomes
| Sequence: | 177016882 | Sequence: | 177016883 | Sequence: | 177016884 | Sequence: | 177016885 | Sequence: | 177016886 | Sequence: | 177016887 | Sequence: | 177016888 | Sequence: | 177016889 | Sequence: | 177016890 | Sequence: | 177016891 | Sequence: | 177016892 | Sequence: | 177016893 | Sequence: | 177016894 | Sequence: | 177016895 | Sequence: | 177016896 | Sequence: | 177016897 | Sequence: | 177016898 | Sequence: | 177016899 | Sequence: | 177016900 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Incidence of Adverse Events | Measure | Incidence of Serious Adverse Events | Measure | Incidence of biopsy-proven kidney allograft rejection | Measure | Time to diagnosis of biopsy-proven kidney allograft rejection | Measure | Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection | Measure | Incidence of graft loss | Measure | Time to graft loss | Measure | Change in estimated glomerular filtration rate (eGFR) over time | Measure | Incidence of delayed graft function | Measure | Percent Change in anti-HLA alloantibodies | Measure | Mean Fluorescence Intensity Change in anti-HLA alloantibodies | Measure | Change in Calculated panel-reactive antibody (cPRA) over time | Measure | Percent Change in donor-specific anti-HLA alloantibodies | Measure | Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies | Measure | Incidence of de novo anti-HLA alloantibody development | Measure | Serum Concentrations of Ig classes (IgG, IgA, and IgM) over time | Measure | Percent change from baseline of circulating serum concentrations of Ig classes | Measure | Serum Concentration of R5458 | Measure | Serum Concentration of R5459 |
| Time Frame | Up to 12 months post-kidney transplant | Time Frame | Up to 12 months post-kidney transplant | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to Day 7 | Time Frame | Up to 12 months | Time Frame | Up to 12 months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months | Time Frame | Up to 12 Months |
| Description | 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) | Description | 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) | Description | 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) | Description | Incidence of graft loss (defined as becoming dialysis-dependent) by 12 months | Description | Time to graft loss (defined as becoming dialysis-dependent) by 12 months | Description | Incidence of delayed graft function (defined as the use of dialysis within 7 days posttransplant) | Description | 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 | Description | 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 | Description | Percent Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels | Description | Mean Fluorescence Intensity Change in donor-specific anti-HLA alloantibodies compared with recipient pre-transplant anti-HLA alloantibody levels | Description | Cumulative incidence of de novo anti-HLA alloantibody development by SAB assay by 12 months | Description | Percent change from baseline of circulating serum concentrations of Ig classes (IgG, IgA, and IgM) |
Browse Conditions
| Sequence: | 193067413 | Sequence: | 193067414 | Sequence: | 193067415 | Sequence: | 193067416 | Sequence: | 193067417 | Sequence: | 193067418 | Sequence: | 193067419 | Sequence: | 193067420 | Sequence: | 193067421 | Sequence: | 193067422 | Sequence: | 193067423 |
| Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48221825 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Regeneron Pharmaceuticals |
Overall Officials
| Sequence: | 29223931 |
| Role | Study Director |
| Name | Clinical Trial Management |
| Affiliation | Regeneron Pharmaceuticals |
Central Contacts
| Sequence: | 11986831 |
| Contact Type | primary |
| Name | Clinical Trials Administrator |
| Phone | 844-734-6643 |
| clinicaltrials@regeneron.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68008877 |
| Design Group Id | 55478015 |
| Intervention Id | 52378569 |
Eligibilities
| Sequence: | 30704071 |
| Sampling Method | Non-Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 70 Years |
| Healthy Volunteers | No |
| Population | 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 REGN5459 or REGN5458 in study R5459- RT-1944. |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253922202 |
| Number Of Facilities | 4 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 70 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 17 |
Designs
| Sequence: | 30450692 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28817170 |
| Responsible Party Type | Sponsor |