Kidney Transplant RejectionPhase 2NCT05983770
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
A Phase 2 study testing AT-1501 and Tacrolimus in people with Kidney Transplant Rejection, run by Eledon Pharmaceuticals at 43 sites in 7 countries.
Trial summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- AT-1501 and Tacrolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 43 sitesin 7 countries
- Study dates
- 30 Aug 2023to 25 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 5b. Kidney Donor Profile Index (KDPI) of > 85%; Or
- 5c. Is blood group (ABO) incompatible
- Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
- History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
- Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Trial locations and contacts
43 sites in 7 countries.
43 sites in 7 countries
United States27 sites
Emory University Hospital
Atlanta, Georgia, 30322
Augusta University
Augusta, Georgia, 30912
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts General Hospita;
Boston, Massachusetts, 02114
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
UT Southwestern
Dallas, Texas, 75235
Henry Ford Health System
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
University of Pittsburgh Medical Center
Harrisburg, Pennsylvania, 17104
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California Los Angeles
Los Angeles, California, 90024
Keck School of Medicine of USC
Los Angeles, California, 90033
University of Wisconsin Health
Madison, Wisconsin, 53792
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Tulane Medical Center
New Orleans, Louisiana, 70112
New York University Langone Health - Tisch Hospital
New York, New York, 10016
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California, Irvine Medical Center
Orange, California, 92868
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55907
University of California, Davis Medical Center
Sacramento, California, 95817
University of Washington Medical Center
Seattle, Washington, 98195
Washington University in St. Louis
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
France5 sites
Groupe Hospitalier Pellegrin
Bordeaux
CHU Grenoble-Alpes - Hopital Nord Michallon
Grenoble
Centre Hospitalier Universitaire Dupuytren
Limoges, 87042
CHU de Toulouse - Hopital de Rangueil
Toulouse
CHRU Tours - Hopital Bretonneau
Tours
Spain5 sites
Hospital del Mar - Parc de Salut Mar
Barcelona, 08003
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Germans Trias i Pujol
Barcelona
Hospital Universitari de Bellvitge
Barcelona
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Fiona Stanley Hospital
Perth, Western Australia, 6150
Brazil2 sites
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo
Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo
About this study
Official title: AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Read the detailed 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.
- Conditions
- Kidney Transplant Rejection
- Being tested
- AT-1501, Tacrolimus
- Keywords
- AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, Tegoprubart
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-1501Drug
Also called Tegoprubart
IV infusions of AT-1501 20 mg/kg over 1 hour.
TacrolimusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Investigative | Experimental | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion Receives: Drug: AT-1501 |
| Comparator | Active comparator | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR at 12 months
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Measured: Assessed from date of transplant through Day 364 (Month 12)
Secondary outcomes (4)
NODAT at 12 months post-transplant
The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
Measured: Assessed from date of transplant through Day 364 (Month 12
The proportion of patient and graft survival at 12 months post-transplant
Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
Measured: Assessed from date of transplant through Day 364 (Month 12)
BPAR-free patient and graft survival at 12 months post-transplant
Assessed from date of transplant through Day 364 (Month 12)
Measured: The proportion of BPAR-free patient and graft survival at 12 months post-transplant
BPAR at 12 months
The proportion of BPAR at 12 months
Measured: Assessed from date of transplant through Day 364 (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start30 Aug 2023
- Primary completion11 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eledon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983770
- Sponsor's protocol ID
- AT-1501-K207
- Other IDs
- 2023-503336-41-00, U1111-1278-5225, 2023
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05983770
- Acronym / sponsor ID
- AT-1501-K207
- Conditions
- Kidney Transplant Rejection
- Keywords
- AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Eledon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigative | Experimental | Drug: AT-1501AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Comparator | Active comparator | Drug: TacrolimusTacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-1501Also: TegoprubartIV infusions of AT-1501 20 mg/kg over 1 hour. | Drug | Investigative |
| TacrolimusTacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter. | Drug | Comparator |
Primary outcome
eGFR at 12 months
Time frame: Assessed from date of transplant through Day 364 (Month 12)
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
4 secondary outcomes
NODAT at 12 months post-transplant
Time frame: Assessed from date of transplant through Day 364 (Month 12
The proportion of patient and graft survival at 12 months post-transplant
Time frame: Assessed from date of transplant through Day 364 (Month 12)
BPAR-free patient and graft survival at 12 months post-transplant
Time frame: The proportion of BPAR-free patient and graft survival at 12 months post-transplant
BPAR at 12 months
Time frame: Assessed from date of transplant through Day 364 (Month 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
43 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-1501 and Tacrolimus in people with Kidney Transplant Rejection, run by Eledon Pharmaceuticals at 43 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, France, Spain, Australia, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR at 12 months (time frame: Assessed from date of transplant through Day 364 (Month 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.