Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06503731 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)

A Phase 2 study of Antibody-mediated Rejection, sponsored by argenx.

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
20
Study locations

NCT06503731 is a Phase 2 study of Antibody-mediated Rejection that is actively recruiting participants, run by argenx. The registered enrollment target is 30 participants, below the 166-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06503731, a Phase 2 study of Antibody-mediated Rejection, is actively recruiting participants, sponsored by argenx.

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation. After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Conditions Studied

Antibody-mediated Rejection

Interventions

  • COMBINATION_PRODUCT Efgartigimod PH20 SC - prefilled syringe
  • OTHER Placebo PH20 SC - prefilled syringe

Study Locations (20)

Other

  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus - Vienna
  • Universitair Ziekenhuis (UZ) Gent - Ghent
  • Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg - Leuven
  • London Health Sciences Centre - London
  • Institut klinicke a experimentalni mediciny (IKEM) - Prague
  • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin - Bordeaux
  • Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon - La Tronche
  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil - Toulouse
  • Charité - Universitätsmedizin Berlin - Berlin
  • Universitaetsklinikum Carl Gustav Carus Dresden - Dresden
  • Universitätsklinikum Hamburg-Eppendorf - Hamburg
  • Hospital Del Mar - Barcelona

Alabama

  • University of Alabama at Birmingham (UAB) Hospital - Birmingham

California

  • Cedars-Sinai Medical Center - Los Angeles

Illinois

  • University of Chicago Medical Center - Chicago

Nebraska

  • University of Nebraska Medical Center - Omaha

North Carolina

  • Duke University Hospital - Durham

Ohio

  • The Ohio State University Wexner Medical Center - Columbus

Virginia

  • Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center - Richmond

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-08-30
Est. Completion 2027-09
Phase Phase 2

Sponsor

argenx

49 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06503731

The ClinicalTrials.gov registry entry for NCT06503731 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 166-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (82% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Antibody-mediated Rejection appearing as the primary indexed condition, and to 2 interventions - of which Efgartigimod PH20 SC - prefilled syringe is the first listed.

NCT06503731 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Alabama, California.

Frequently Asked Questions

What is clinical trial NCT06503731 about?

NCT06503731 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)". The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation. After a screening period of up to 6 weeks, eligible participants will be randomized...

What is the current status of trial NCT06503731?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-08-30. Estimated completion is 2027-09.

What conditions does trial NCT06503731 study?

This clinical trial studies the following conditions: Antibody-mediated Rejection.

What interventions are being tested in trial NCT06503731?

The interventions under investigation include: Efgartigimod PH20 SC - prefilled syringe (COMBINATION_PRODUCT), Placebo PH20 SC - prefilled syringe (OTHER).

Who is sponsoring clinical trial NCT06503731?

This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06503731 being conducted?

This trial has 20 study locations across Alabama, California, Illinois, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Antibody-mediated Rejection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Antibody-mediated Rejection

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.