Clinical Trials in Spain / NCT06126380
Enrolling by invitation
Phase 2
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
NCT06126380 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Kidney Transplant Rejection
Investigational drug(s) / intervention(s)
AT-1501: 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
Tacrolimus: 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
Study summary
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
Eligibility
Inclusion Criteria:
* Successfully completed qualifying Parent study, where entry into the OLE was offered;
* Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
* Agree not to participate in another interventional study while on treatment;
* If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
* If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.
Exclusion Criteria:
* Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
* Met any of the stopping criteria or discontinued study drug in the Parent study;
* Pregnant or breastfeeding.
Primary outcome measure(s)
- Safety and Tolerability - Incidence of Treatment Emergent Adverse Events — Assessed from date of enrollment through Month 48
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI). - Safety and Tolerability - Kidney Transplant Medication Side Effects — Assessed from date of enrollment through Month 48
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.
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | |
| Keck School of Medicine of USC | Los Angeles | California | |
| University of California, Irvine Medical Center | Orange | California | |
| University of California, Davis Medical Center | Sacramento | California | |
| Jacobs Medical Center at UC San Diego Health | San Diego | California | |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| Tampa General Hospital | Tampa | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Augusta University | Augusta | Georgia | |
| University of Chicago | Chicago | Illinois | |
| Loyola University Medical Center | Maywood | Illinois | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Tulane Medical Center | New Orleans | Louisiana | |
| John Hopkins University | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| University of Minnesota Medical Center | Minneapolis | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Washington University in St. Louis | St Louis | Missouri | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| New York University Langone Health - Tisch Hospital | New York | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| University of Cincinnati Medical Center | Cincinnati | Ohio | |
| University of Pittsburgh Medical Center | Harrisburg | Pennsylvania | |
| UT Southwestern | Dallas | Texas | |
| Virginia Commonwealth University | Richmond | Virginia | |
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Fiona Stanley Hospital | Perth | Western Australia | |
| Fundação Oswaldo Ramos - Hospital do Rim | São Paulo | Brazil | |
| Hospital das Clínicas da Faculdade de Medicina de São Paulo | São Paulo | Brazil | |
| St. Paul's Hospital | Vancouver | British Columbia | |
| McGill University Health Care Centre | Montreal | Quebec | |
| Groupe Hospitalier Pellegrin | Bordeaux | France | |
| CHU Grenoble-Alpes - Hopital Nord Michallon | Grenoble | France | |
| Centre Hospitalier Universitaire Dupuytren | Limoges | France | |
| CHU de Toulouse - Hopital de Rangueil | Toulouse | France | |
| Charite Universitatsmedizin Berlin | Berlin | Germany | |
| Hospital del Mar - Parc de Salut Mar | Barcelona | Spain | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Clinical de Barcelona | Barcelona | Spain |
+ 3 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06126380 on ClinicalTrials.gov ↗ ← All trials in Spain