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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1 to month 3, 6, 12, and 15 post-transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have received my first kidney transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1 to month 3, 6, 12, and 15 post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 to month 3, 6, 12, and 15 post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetic- (Vdss)
Pharmacokinetic- (t1/2)
Pharmacokinetic- Area under the plasma concentration
+6 moreOther outcome measures
Anti-AT-1501 antibody studies
Change in eGFR
Incidence of BPAR
+5 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0432214944%
Fatigue
33%
Headache
22%
Depression
22%
Dizziness
22%
Muscle spasms
22%
Musculoskeletal stiffness
11%
Post-traumatic pain
11%
Dermatitis contact
11%
Muscle twitching
11%
Confusional state
11%
Prostatitis
11%
Feeling jittery
11%
Diarrhoea
11%
Affect lability
11%
Hypoaesthesia
11%
Abdominal pain upper
11%
Neuropathy peripheral
11%
Muscular weakness
11%
Neck pain
11%
Actinic keratosis
11%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
AT-1501 1.0 mg/kg
AT-1501 2.0 mg/kg
AT-1501 4.0 mg/kg
AT-1501 8.0 mg/kg
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My kidney donor matches one of the specific criteria needed.I have never been treated with AT 1501 or any anti CD40LG therapy.I am not on strong immune system suppressing drugs, except for a low dose of prednisone.I am planned to receive a specific initial immune system treatment other than rATG.I have a history of blood clots but don't need long-term blood thinners.I have had or will have a bone marrow or solid organ transplant.I have received my first kidney transplant.My kidney transplant will involve a delay of over 30 hours before transplantation.
Research Study Groups:
This trial has the following groups:- Group 1: AT-1501 Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many candidates are being enrolled in this experiment?
"That is correct. The clinical trial, which was created on February 18th, 2022, is still recruiting patients as of May 16th, 2022. Up to 12 people can join the study at a single site."
Answered by AI
How do I qualify to participate in this research?
"To qualify for this study, patients must have functioning kidneys and be within the age range of 18 to 100. So far, 12 people have been enrolled in the trial."
Answered by AI
Are there any current vacancies for this clinical trial?
"Yes, an updated on clinicaltrials.gov today shows that this study is still looking for participants. The trial was first posted on February 18th, 2022 and was last edited on May 16th, 2022. They are currently recruiting 12 people from 1 site."
Answered by AI
Could you explain the age limit for those who can take part in this particular research project?
"The age bracket for this study is 18-100 years old."
Answered by AI
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