NCT_ID: NCT05983770
Clinical Trial Link
Brief Summaries
| Sequence: | 30870447 |
| Description | This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation. |
Studies
| Study First Submitted Date | 2023-08-02 |
| Study First Posted Date | 2023-08-09 |
| Last Update Posted Date | 2023-08-09 |
| Start Month Year | August 2023 |
| Primary Completion Month Year | March 2025 |
| Verification Month Year | August 2023 |
| Verification Date | 2023-08-31 |
| Last Update Posted Date | 2023-08-09 |
Detailed Descriptions
| Sequence: | 20791674 |
| Description | This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus. |
Facilities
| Sequence: | 200693960 | Sequence: | 200693961 |
| Status | Recruiting | Status | Recruiting |
| Name | Washington University in St. Louis | Name | Virginia Commonwealth University |
| City | Saint Louis | City | Richmond |
| State | Missouri | State | Virginia |
| Zip | 63110 | Zip | 23298 |
| Country | United States | Country | United States |
Browse Interventions
| Sequence: | 96333959 | Sequence: | 96333960 | Sequence: | 96333961 | Sequence: | 96333962 | Sequence: | 96333963 | Sequence: | 96333964 | Sequence: | 96333965 |
| Mesh Term | Tacrolimus | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Calcineurin Inhibitors | Mesh Term | Enzyme Inhibitors | Mesh Term | Molecular Mechanisms of Pharmacological Action |
| Downcase Mesh Term | tacrolimus | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | calcineurin inhibitors | Downcase Mesh Term | enzyme inhibitors | Downcase Mesh Term | molecular mechanisms of pharmacological action |
| 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 |
Conditions
| Sequence: | 52350287 |
| Name | Kidney Transplant Rejection |
| Downcase Name | kidney transplant rejection |
Id Information
| Sequence: | 40286994 | Sequence: | 40286995 | Sequence: | 40286996 |
| Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id |
| Id Value | AT-1501-K207 | Id Value | 2023-503336-41-00 | Id Value | U1111-1278-5225 |
| Id Type | Other Identifier | Id Type | Other Identifier | ||
| Id Type Description | European Clinical Trial Register | Id Type Description | World Health Organization | ||
Countries
| Sequence: | 42708526 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55793325 | Sequence: | 55793326 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Investigative | Title | Comparator |
| Description | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion | Description | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
Interventions
| Sequence: | 52661649 | Sequence: | 52661650 |
| Intervention Type | Drug | Intervention Type | Drug |
| Name | AT-1501 | Name | Tacrolimus |
| Description | IV infusions of AT-1501 20 mg/kg over 1 hour. | Description | Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter. |
Keywords
| Sequence: | 80116339 | Sequence: | 80116336 | Sequence: | 80116337 | Sequence: | 80116338 | Sequence: | 80116340 | Sequence: | 80116341 | Sequence: | 80116342 | Sequence: | 80116343 | Sequence: | 80116344 | Sequence: | 80116345 | Sequence: | 80116346 |
| Name | Prophylaxis | Name | AT-1501 | Name | Kidney Transplant | Name | Renal Allograft Rejection | Name | CD40L Inhibitor | Name | Humanized blocking antibody to CD40L | Name | Monoclonal Antibody | Name | Renal | Name | Transplant | Name | ESRD | Name | Tegoprubart |
| Downcase Name | prophylaxis | Downcase Name | at-1501 | Downcase Name | kidney transplant | Downcase Name | renal allograft rejection | Downcase Name | cd40l inhibitor | Downcase Name | humanized blocking antibody to cd40l | Downcase Name | monoclonal antibody | Downcase Name | renal | Downcase Name | transplant | Downcase Name | esrd | Downcase Name | tegoprubart |
Design Outcomes
| Sequence: | 178041372 | Sequence: | 178041373 | Sequence: | 178041374 | Sequence: | 178041375 | Sequence: | 178041376 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | eGFR at 12 months | Measure | NODAT at 12 months post-transplant | Measure | The proportion of patient and graft survival at 12 months post-transplant | Measure | BPAR-free patient and graft survival at 12 months post-transplant | Measure | BPAR at 12 months |
| Time Frame | Assessed from date of transplant through Day 364 (Month 12) | Time Frame | Assessed from date of transplant through Day 364 (Month 12 | Time Frame | Assessed from date of transplant through Day 364 (Month 12) | Time Frame | The proportion of BPAR-free patient and graft survival at 12 months post-transplant | Time Frame | Assessed from date of transplant through Day 364 (Month 12) |
| Description | Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant | Description | The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant | Description | Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis | Description | Assessed from date of transplant through Day 364 (Month 12) | Description | The proportion of BPAR at 12 months |
Sponsors
| Sequence: | 48486889 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Eledon Pharmaceuticals |
Central Contacts
| Sequence: | 12053984 |
| Contact Type | primary |
| Name | Eledon Pharmaceuticals |
| Phone | 949-238-8090 |
| clinicaltrials@eledon.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68393196 | Sequence: | 68393197 |
| Design Group Id | 55793325 | Design Group Id | 55793326 |
| Intervention Id | 52661649 | Intervention Id | 52661650 |
Eligibilities
| Sequence: | 30869228 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 100 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Male or female ≥ 18 years of age Recipient of their first kidney transplant from a living or deceased donor Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug Exclusion Criteria: Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies Currently treated with corticosteroids other than topical or inhaled corticosteroids Will receive a kidney with an anticipated cold ischemia time of > 30 hours Will receive a kidney from a donor that meets any of the following: 5a. Donation after Cardiac Death (DCD) criteria; Or 5b. Kidney Donor Profile Index (KDPI) of > 85%; Or 5c. Is blood group (ABO) incompatible 6. Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants 7. History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254021609 |
| Number Of Facilities | 2 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 100 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 4 |
Designs
| Sequence: | 30615037 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Intervention Other Names
| Sequence: | 26758650 |
| Intervention Id | 52661649 |
| Name | Tegoprubart |
Responsible Parties
| Sequence: | 28981563 |
| Responsible Party Type | Sponsor |