Prevention of Rejection in Kidney TransplantPhase 1/2NCT05027906
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
A Phase 1/2 study testing AT-1501 in people with Prevention of Rejection in Kidney Transplant, run by Eledon Pharmaceuticals at 9 sites in 5 countries.
Trial summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prevention of Rejection in Kidney Transplant
- What is being tested?
- AT-1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 18 Feb 2022to Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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, with the exception of 5 mg prednisone or equivalent daily;
- Previous treatment with AT 1501 or any other anti CD40LG therapy
- The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
- 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 criteria:
Show all 17Show fewer
- Donation after Cardiac Death (DCD) criteria; or
- Extended Criteria Donor (ECD) criteria, defined as:
- Is blood group (ABO) incompatible; or
- Age ≥ 60 years; or Age 50-59 years with any 2 of the following criteria:
- Death due to cerebrovascular accident
- History of hypertension
- Terminal creatinine ≥ 133 μmol/L (1.5 mg/dL)
- Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
- Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
- History of a TE 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
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Canada3 sites, 3 recruiting
- Recruiting
McGill University Health Care Centre
Montreal, Quebec, H4A 3J1
Research Staff
- Recruiting
Providence Health Care - St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Research Staff
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V6Z 1Y6
Research Staff
Australia2 sites, 2 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, SA 5000
Research Staff
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Research Staff
United Kingdom2 sites, 2 recruiting
- Recruiting
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, L78XP
Research Staff
- Recruiting
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford, OX3 9DU
Research Staff
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Research Staff
Brazil1 site, 1 recruiting
- Recruiting
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo
Research Staff
About this study
Official title: A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Read the detailed description
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
- Being tested
- AT-1501
- Keywords
- Kidney Transplant, Renal Allograft Rejection, Prophylaxis, AT-1501, 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
Investigative Arm
| Study group | Role | What they receive |
|---|---|---|
| AT-1501 Single Arm | Experimental | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion Receives: Drug: AT-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Incidences
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
Measured: Through study completion, an average up to 20 months
Pharmacokinetic- PK profile
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- Area under the plasma concentration
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- Cmax
Maximum observed plasma concentration (Cmax)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- Tmax
Time to reach maximum observed plasma concentration (Tmax)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- Ke
Terminal elimination rate constant (Ke)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- (t1/2)
Terminal phase half-life (t1/2)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- CL
Clearance (CL)
Measured: Day 1 and at steady state Month 3
Pharmacokinetic- (Vdss)
Volume of distribution at steady state (Vdss)
Measured: Day 1 and at steady state Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start18 Feb 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Rejection in Kidney TransplantStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1b, open label, single-arm study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eledon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027906
- Sponsor's protocol ID
- AT-1501-K102
- Other IDs
- 2021-003830-36
- Status last verified
- Jun 2025
- First submitted
- 19 Aug 2021
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
- ClinicalTrials.gov ID
- NCT05027906
- Acronym / sponsor ID
- AT-1501-K102
- Keywords
- Kidney Transplant, Renal Allograft Rejection, Prophylaxis, AT-1501, CD40L inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Eledon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Aug 2021 (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, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Detailed description
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1b, open label, single-arm study
| Arm | Type | Receives |
|---|---|---|
| AT-1501 Single Arm | Experimental | Drug: AT-1501AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
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 (17 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, with the exception of 5 mg prednisone or equivalent daily;
- Previous treatment with AT 1501 or any other anti CD40LG therapy
- The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
- Will receive a kidney with an anticipated cold ischemia time of > 30 hours;
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-1501Investigative Arm | Drug | AT-1501 Single Arm |
Primary outcome
Safety Incidences
Time frame: Through study completion, an average up to 20 months
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
Pharmacokinetic- PK profile
Time frame: Day 1 and at steady state Month 3
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Pharmacokinetic- Area under the plasma concentration
Time frame: Day 1 and at steady state Month 3
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Pharmacokinetic- Cmax
Time frame: Day 1 and at steady state Month 3
Maximum observed plasma concentration (Cmax)
Pharmacokinetic- Tmax
Time frame: Day 1 and at steady state Month 3
Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic- Ke
Time frame: Day 1 and at steady state Month 3
Terminal elimination rate constant (Ke)
Pharmacokinetic- (t1/2)
Time frame: Day 1 and at steady state Month 3
Terminal phase half-life (t1/2)
Pharmacokinetic- CL
Time frame: Day 1 and at steady state Month 3
Clearance (CL)
Pharmacokinetic- (Vdss)
Time frame: Day 1 and at steady state Month 3
Volume of distribution at steady state (Vdss)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Prevention of Rejection in Kidney Transplant
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Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
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BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
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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.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AT-1501 in people with Prevention of Rejection in Kidney Transplant, run by Eledon Pharmaceuticals at 9 sites in 5 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 17 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: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Australia, United Kingdom, United States, Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eledon Pharmaceuticals (949-238-8090, clinicaltrials@eledon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Incidences (time frame: Through study completion, an average up to 20 months). The study lists 9 primary outcomes in all. 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 29 Jun 2025.