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
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