Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

NCT06126380 · tracked via the Priya Life Science UK tracker

Sponsor

Eledon Pharmaceuticals

Phase

Phase 2

Started

2023-10-25

Last updated

2025-12-10

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

AT-1501Tacrolimus

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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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
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.

More Eledon Pharmaceuticals trials in the UK

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant Recruiting

Other trials for the same condition

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term) Active, not recruiting

Clinical Impact of the IBox As an Early Intervention TooL Active, not recruiting

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 the UK