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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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
eGFR at 12 months
Secondary study objectives
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
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

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
~20 spots leftby Mar 2025
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