← Back to Search

Monoclonal Antibodies

Tegoprubart for Kidney Transplant Rejection

Phase 2
Waitlist Available
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 assessed from date of enrollment through month 48
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare a new medicine to tacrolimus for kidney transplant patients to see if it's safe and effective long-term.

Who is the study for?
This trial is for kidney transplant recipients who completed a prior study and consent to continue. They must understand the study, not join other trials, and if of childbearing potential, use effective contraception. Women must be sterile, postmenopausal or have a negative pregnancy test; men must also agree to contraception.
What is being tested?
The trial compares long-term safety and effectiveness of two drugs in preventing kidney transplant rejection: Tegoprubart (AT-1501) versus Tacrolimus. Participants previously involved in related research will receive one of these treatments to determine which is better over time.
What are the potential side effects?
While specific side effects are not listed here, both Tegoprubart and Tacrolimus can potentially cause immune system changes leading to increased infection risk, possible organ toxicity, blood pressure variations, tremors, headaches and gastrointestinal issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from date of enrollment through month 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from date of enrollment through month 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
Safety and Tolerability - Kidney Transplant Medication Side Effects
Secondary study objectives
Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
Proportion of participants with BPAR at 12, 24, 36, and 48 months
The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months
+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: AT-1501Experimental Treatment1 Intervention
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
Group II: TacrolimusActive Control1 Intervention
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
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
168 Total Patients Enrolled
~88 spots leftby Dec 2029
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