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| ID | Type | Description | Link |
|---|---|---|---|
| EU CTR | Other Identifier | 2023-503337-11-00 | |
| UTN | Other Identifier | U1111-1284-6127 |
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This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.
The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.
Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-1501 | Experimental | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
|
| Tacrolimus | Active Comparator | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-1501 | Drug | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability - Incidence of Treatment Emergent Adverse Events | Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI). | Assessed from date of enrollment through Month 48 |
| Safety and Tolerability - Kidney Transplant Medication Side Effects | Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months. | Assessed from date of enrollment through Month 48 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patient and graft survival at 12, 24, 36, and 48 months | A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2. | Assessed from date of enrollment through Month 48 |
| The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90024 | United States | ||
| Keck School of Medicine of USC |
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|
| Tacrolimus | Drug | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
|
A participant is considered to have graft functional impairment if they have an eGFR <60 mL/min/1.73m^2. |
| Assessed from date of enrollment through Month 48 |
| Proportion of participants with BPAR at 12, 24, 36, and 48 months | The Proportion of participants with BPAR at 12, 24, 36, and 48 months. | Assessed from date of enrollment through Month 48 |
| Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months | The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months. | Assessed from date of enrollment through Month 48 |
| Los Angeles |
| California |
| 90033 |
| United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| Jacobs Medical Center at UC San Diego Health | San Diego | California | 92037 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| John Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55907 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| New York University Langone Health - Tisch Hospital | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University of Pittsburgh Medical Center | Harrisburg | Pennsylvania | 17104 | United States |
| UT Southwestern | Dallas | Texas | 75235 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Fiona Stanley Hospital | Perth | Western Australia | 6150 | Australia |
| Fundação Oswaldo Ramos - Hospital do Rim | São Paulo | 04038-002 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina de São Paulo | São Paulo | 05403-010 | Brazil |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z IY6 | Canada |
| McGill University Health Care Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Groupe Hospitalier Pellegrin | Bordeaux | France |
| CHU Grenoble-Alpes - Hopital Nord Michallon | Grenoble | 38700 | France |
| Centre Hospitalier Universitaire Dupuytren | Limoges | 07042 | France |
| CHU de Toulouse - Hopital de Rangueil | Toulouse | 31400 | France |
| Charite Universitatsmedizin Berlin | Berlin | Germany |
| Hospital del Mar - Parc de Salut Mar | Barcelona | 08003 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinical de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| 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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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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