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Monoclonal Antibodies

Tegoprubart for Kidney Transplant Rejection

Q: How does the safety profile of AT-1501 compare with other treatments?

Our assessment at Power has concluded that AT-1501 falls on the spectrum of safety somewhere between 1 and 3, likely a 2. This is due to there being some data attesting its security but no evidence of clinical benefit in Phase 2 trials.

Q: What criteria must individuals meet in order to participate in this experiment?

This <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> trial is accepting candidates aged between 18 and 100 that have experienced <a href="https://www.withpower.com/clinical-trials/kidney-transplant">kidney transplant</a> rejection. In total, 132 individuals will be enrolled for the study.

Q: Does the age limit for this research include people under thirty years of age?

The requirements to be included in this trial is that individuals are between 18 and 100 years old. There are 4 trials specifically for minors, whereas the elderly may participate in 28 other studies.

Q: Is admission to the trial currently available for those seeking treatment?

Clinicaltrials.gov suggests that this study is no longer accepting participants, as it was posted on October 25th 2023 and last updated November 6th 2023. However, there are 28 other trials actively recruiting patients right now.

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from date of enrollment through month 48

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability - Incidence of Treatment Emergent Adverse Events

Safety and Tolerability - Kidney Transplant Medication Side Effects

Secondary outcome measures

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

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%

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: 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eledon PharmaceuticalsLead Sponsor

4 Previous Clinical Trials

168 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes is this trial intending to accomplish?

"This clinical trial is set to last until Month 48 and its primary goal is assessing the effects of kidney transplant medication on safety and tolerance. Secondary outcomes include percentages of patient/graft survival, participants with graft functional impairment (eGFR <60 mL/min/1.73m^2) at several intervals, as well as proportions of patients with BPAR (Biopsy Proven Acute Rejection)."

Answered by AI

How does the safety profile of AT-1501 compare with other treatments?

"Our assessment at Power has concluded that AT-1501 falls on the spectrum of safety somewhere between 1 and 3, likely a 2. This is due to there being some data attesting its security but no evidence of clinical benefit in Phase 2 trials."

Answered by AI

What criteria must individuals meet in order to participate in this experiment?

"This experimental trial is accepting candidates aged between 18 and 100 that have experienced kidney transplant rejection. In total, 132 individuals will be enrolled for the study."

Answered by AI

Does the age limit for this research include people under thirty years of age?

"The requirements to be included in this trial is that individuals are between 18 and 100 years old. There are 4 trials specifically for minors, whereas the elderly may participate in 28 other studies."

Answered by AI

Is admission to the trial currently available for those seeking treatment?

"Clinicaltrials.gov suggests that this study is no longer accepting participants, as it was posted on October 25th 2023 and last updated November 6th 2023. However, there are 28 other trials actively recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

2023. "Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126380.

All > Kidney Transplant