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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ the proportion of bpar-free patient and graft survival at 12 months post-transplant

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%

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

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

How many participants are included in this clinical investigation?

"That is correct. As indicated on clinicaltrials.gov, this medical investigation was initially posted on August 1st 2023 and subsequently modified on the 2nd of that same month. The inquiry necessitates 120 participants from two distinct facilities to meet its criteria."

Answered by AI

Does this clinical experiment accept volunteers above the age of twenty?

"This medical trial is seeking patients aged 18 and over, but younger than 100 years old."

Answered by AI

Does the FDA recognize Investigational as a valid form of treatment?

"Since this is a Phase 2 trial, meaning safety has been previously studied but no efficacy data exists yet, our group at Power granted Investigative a rating of 2 on the scale."

Answered by AI

How can I participate in this medical research?

"To participate, patients must meet the conditions of kidney transplant rejection and be between 18-100 years old. Currently, this trial is seeking to enrol 120 individuals."

Answered by AI

Are there still openings to take part in this research endeavor?

"Affirmative. According to the clinicaltrials.gov database, recruitment for this trial is currently ongoing and was last updated on August 2nd 2023 - having first gone live on August 1st of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

2023. "Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05983770.

All > Kidney Transplant