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Monoclonal Antibodies

AT-1501 for Kidney Transplant

Phase 1 & 2
Recruiting
Research Sponsored by Eledon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥ 18 years of age
Recipient of their first kidney transplant from a living or deceased donor
Must not have
Previous treatment with AT 1501 or any other anti CD40LG therapy
Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 to month 3, 6, 12, and 15 post-transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial will study a new drug to see if it is safe and effective in kidney transplant patients.

Who is the study for?
This trial is for adults over 18 receiving their first kidney transplant from a living or deceased donor. It's not for those who've had previous transplants, are on current immunosuppressives (except low-dose prednisone), have used AT-1501 or similar drugs before, or will get kidneys with long cold times (>30 hours) or from donors meeting certain criteria like age and health conditions.
What is being tested?
The study tests the safety, how the body processes (pharmacokinetics), and effectiveness of a drug called AT-1501 in patients getting a kidney transplant. Participants will receive this medication to see if it helps prevent organ rejection without causing significant harm.
What are the potential side effects?
While specific side effects aren't listed here, generally such trials look out for any new medical issues that arise during treatment—like allergic reactions, infections due to weakened immunity, liver problems, blood disorders—or anything else unusual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I have received my first kidney transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have never been treated with AT 1501 or any anti CD40LG therapy.
Select...
I am planned to receive a specific initial immune system treatment other than rATG.
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I have had or will have a bone marrow or solid organ transplant.
Select...
My kidney transplant will involve a delay of over 30 hours before transplantation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 to month 3, 6, 12, and 15 post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 to month 3, 6, 12, and 15 post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetic- (Vdss)
Pharmacokinetic- (t1/2)
Pharmacokinetic- Area under the plasma concentration
+6 more
Other study objectives
Anti-AT-1501 antibody studies
Change in eGFR
Incidence of BPAR
+5 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT04322149
39%
Fatigue
22%
Fall
17%
Headache
17%
Nasopharyngitis
11%
Somnolence
11%
Nausea
11%
Hand fracture
11%
Muscle spasms
11%
Arthralgia
11%
Muscular weakness
11%
Dyspnoea
6%
Micturition urgency
6%
Dysphagia
6%
Dizziness
6%
Aphasia
6%
Migraine
6%
Foot fracture
6%
Salivary hypersecretion
6%
Depression
6%
Disorientation
6%
Nasal congestion
6%
Throat clearing
6%
Rash
6%
Blood pressure increased
6%
Cardiac murmur
6%
Weight decreased
6%
Tinnitus
6%
Gait disturbance
6%
Pain
6%
Contusion
6%
Joint range of motion decreased
6%
Abdominal discomfort
6%
Epistaxis
6%
Productive cough
6%
Respiratory tract congestion
6%
Upper respiratory tract infection
6%
Atrial fibrillation
6%
Asthenia
6%
Middle insomnia
6%
Cough
6%
Decreased appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
AT-1501 8.0 mg/kg
AT-1501 1.0 mg/kg
AT-1501 2.0 mg/kg
AT-1501 4.0 mg/kg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AT-1501 Single ArmExperimental Treatment1 Intervention
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AT-1501
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Eledon PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
276 Total Patients Enrolled
Jeff Bornstein, MDStudy ChairEledon Pharmaceuticals
4 Previous Clinical Trials
202 Total Patients Enrolled

Media Library

AT-1501 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05027906 — Phase 1 & 2
Kidney Transplant Research Study Groups: AT-1501 Single Arm
Kidney Transplant Clinical Trial 2023: AT-1501 Highlights & Side Effects. Trial Name: NCT05027906 — Phase 1 & 2
AT-1501 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05027906 — Phase 1 & 2
~5 spots leftby Sep 2025
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