RECRUITING

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)

Conditions

Antibody-mediated Rejection Active AMR Chronic active AMR Late AMR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients with Antibody-Mediated Rejection

Quick Facts

Study Start:2024-08-30

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06503731

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The participant is within the ages of 18 and 80 years old * The participant had a kidney transplant (living or deceased donor) at least 6 months before the study * The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study * A participant may be allowed into the study if they receive the following medications: 1. Received mycophenolate mofetil for at least 20 weeks before the study 2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study 3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study 4. Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study	* Confirmed T-cell or mixed rejection at time of the study * Recent change in immunosuppressive therapy agents * Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk * Pregnant or lactating state or intention to become pregnant during the study

Inclusion Criteria

Exclusion Criteria

* The participant is within the ages of 18 and 80 years old
* The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
* The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
* A participant may be allowed into the study if they receive the following medications:
1. Received mycophenolate mofetil for at least 20 weeks before the study
2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
4. Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study

* Confirmed T-cell or mixed rejection at time of the study
* Recent change in immunosuppressive therapy agents
* Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
* Pregnant or lactating state or intention to become pregnant during the study

Contacts and Locations

Study Contact

Sabine Coppieters, MD

CONTACT

857-350-4834

clinicaltrials@argenx.com

Study Locations (Sites)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

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

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: argenx

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-08-30

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Active AMR
Chronic active AMR
Late AMR

Additional Relevant MeSH Terms

Antibody-mediated Rejection