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

NCT06126380 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 3 other identifiers: AT-1501-K209EU CTRUTN
• Study Type: interventional
• Target: 132
• Locations: 8 countries
• Sites: 43

Brief Summary

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Conditions

Kidney Transplant Rejection

Keywords

Kidney Transplant; AT-1501; Renal Allograft Rejection; Prophylaxis; CD40L Inhibitor; Humanized blocking antibody to CD40L; monoclonal antibody; renal, transplant; ESRD; tegoprubart

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• The proportion of patient and graft survival at 12, 24, 36, and 48 months

  Assessed from date of enrollment through Month 48

• The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months

  Assessed from date of enrollment through Month 48

• 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

  Assessed from date of enrollment through Month 48

Study Arms (2)

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

Drug: AT-1501

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

Drug: Tacrolimus

Interventions

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

Also known as: Tegoprubart

AT-1501

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

Tacrolimus

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eledon Pharmaceuticals: lead

Study Sites (43)

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Jacobs Medical Center at UC San Diego Health

San Diego, California, 92037, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55907, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

New York University Langone Health - Tisch Hospital

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Pittsburgh Medical Center

Harrisburg, Pennsylvania, 17104, United States

Location

UT Southwestern

Dallas, Texas, 75235, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, 04038-002, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, 05403-010, Brazil

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z IY6, Canada

Location

McGill University Health Care Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Groupe Hospitalier Pellegrin

Bordeaux, France

Location

CHU Grenoble-Alpes - Hopital Nord Michallon

Grenoble, 38700, France

Location

Centre Hospitalier Universitaire Dupuytren

Limoges, 07042, France

Location

CHU de Toulouse - Hopital de Rangueil

Toulouse, 31400, France

Location

Charite Universitatsmedizin Berlin

Berlin, Germany

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinical de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); DE (1); FR (4); AU (2); CA (2); BR (2); US (26); ES (5)