← Back to Search

Monoclonal Antibodies

Tegoprubart for Kidney Transplant Rejection

Phase 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the proportion of bpar-free patient and graft survival at 12 months post-transplant
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe & effective for kidney transplant patients, compared to an existing drug.

Who is the study for?
This trial is for adults (18+) who are receiving their first kidney transplant from a living or deceased donor and agree to follow contraception rules post-treatment. It's not for those on chronic steroids/immunosuppressants, with clotting disorders, needing long-term anticoagulation, or previous severe reactions to similar drugs.Check my eligibility
What is being tested?
The study compares the safety and effectiveness of a new drug called Tegoprubart (AT-1501) with Tacrolimus in preventing organ rejection after kidney transplantation. Participants will be randomly assigned to receive one of these treatments.See study design
What are the potential side effects?
Possible side effects may include immune system suppression leading to increased infection risk, potential liver or kidney toxicity, blood pressure changes, tremors, and possible impact on blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the proportion of bpar-free patient and graft survival at 12 months post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and the proportion of bpar-free patient and graft survival at 12 months post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
eGFR at 12 months
Secondary outcome measures
BPAR at 12 months
BPAR-free patient and graft survival at 12 months post-transplant
NODAT at 12 months post-transplant
+1 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT04322149
44%
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

2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigativeExperimental Treatment1 Intervention
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
Group II: ComparatorActive Control1 Intervention
Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
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
180 Total Patients Enrolled

Media Library

AT-1501 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05983770 — Phase 2
Kidney Transplant Rejection Research Study Groups: Investigative, Comparator
Kidney Transplant Rejection Clinical Trial 2023: AT-1501 Highlights & Side Effects. Trial Name: NCT05983770 — Phase 2
AT-1501 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05983770 — Phase 2
~60 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top