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Monoclonal Antibodies

REGN5459 + REGN5458 for Transplant-Ready Chronic Kidney Disease

Q: Is this experiment open to participants who are of advanced age?

In order to be accepted into this medical evaluation, participants must have a minimum age of 18 and cannot exceed the upper limit of 70 years old.

Q: Does this trial currently have open enrollment?

Presently, information on clinicaltrials.gov confirms that this study is actively recruiting participants, as first posted August 2nd 2022 and amended August 17th of the same year.

Q: Is it possible for me to become a participant in this research?

For admittance into this medical study, individuals have to suffer from kidney diseases and must fall within the specified age range (18-70). As of now, enrollment is limited to a total of 60 patients.

Q: How many individuals are currently involved in this research endeavor?

Regeneron Pharmaceuticals is sponsoring this medical study, with the aim of recruiting 60 participants who fulfill its eligibility criteria. The trials will be conducted in several locations including University of <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>-Penn <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Institute (Philadelphia) and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> University Langone Health - Transplant Institute (New York).

Phase 1 & 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 weeks

Awards & highlights

Study Summary

This trial is testing two drugs, REGN5459 and REGN5458, to see if they are safe and tolerable for patients with chronic kidney disease who need a kidney transplant and are highly sensitized to human leukocyte antigen. The secondary objectives are to determine the drug's effect on reducing levels of anti-HLA alloantibodies, on the duration of this effect, and on other immunological measures.

Who is the study for?

This trial is for adults with chronic kidney disease who need a kidney transplant and are highly sensitized to human leukocyte antigen (HLA). They must be on hemodialysis, have been waiting for a transplant with a cPRA ≥99.9%, or have a cPRA >98% if they've been on the waitlist for over 5 years. Participants should not have active cancer, history of certain treatments, recent vaccinations, or specific medical conditions.Check my eligibility

What is being tested?

The study tests REGN5459 (Part A) and REGN5458 (Part B) as potential treatments to reduce anti-HLA alloantibody levels in patients awaiting kidney transplants. It aims to find effective doses, understand how long the drugs work, their impact on immune system proteins, and overall safety.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, changes in blood counts or liver enzymes indicating organ inflammation or damage; allergic reactions; fatigue; headaches; and possible impacts on immune function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe CKD, need dialysis, am on the UNOS waitlist for a kidney, and have a high cPRA score.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study

Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period

Secondary outcome measures

Concentration of REGN5458 in serum over time

Concentration of REGN5459 in serum over time

Duration of a reduction in peak anti-HLA alloantibody to MFI <5,000 or by ≥50% by SAB assay

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: REGN5459Experimental Treatment1 Intervention

REGN5459 escalating dose

Group II: REGN5458Experimental Treatment1 Intervention

REGN5458 escalating dose

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

617 Previous Clinical Trials

380,145 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

260 Previous Clinical Trials

250,982 Total Patients Enrolled

Media Library

REGN5458 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05092347 — Phase 1 & 2

Chronic Kidney Disease Research Study Groups: REGN5459, REGN5458

Chronic Kidney Disease Clinical Trial 2023: REGN5458 Highlights & Side Effects. Trial Name: NCT05092347 — Phase 1 & 2

REGN5458 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092347 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment open to participants who are of advanced age?

"In order to be accepted into this medical evaluation, participants must have a minimum age of 18 and cannot exceed the upper limit of 70 years old."

Answered by AI

Does this trial currently have open enrollment?

"Presently, information on clinicaltrials.gov confirms that this study is actively recruiting participants, as first posted August 2nd 2022 and amended August 17th of the same year."

Answered by AI

Is it possible for me to become a participant in this research?

"For admittance into this medical study, individuals have to suffer from kidney diseases and must fall within the specified age range (18-70). As of now, enrollment is limited to a total of 60 patients."

Answered by AI

How many individuals are currently involved in this research endeavor?

"Regeneron Pharmaceuticals is sponsoring this medical study, with the aim of recruiting 60 participants who fulfill its eligibility criteria. The trials will be conducted in several locations including University of Pennsylvania-Penn Transplant Institute (Philadelphia) and New york University Langone Health - Transplant Institute (New York)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen

2022. "Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05092347.

All > Chronic Kidney Disease > Kidney Transplant