Clinical trial NCT06503731: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Antibody-mediated Rejection
Keywords: Active AMR
Chronic active AMR
Late AMR
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

The complete list of criteria can be found in the protocol

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 78 weeks
measure: Percentage of participants with permanent treatment discontinuation due to adverse events (AEs)
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR)
timeFrame: Up to 72 weeks
measure: Histological changes in kidney biopsy
timeFrame: Up to 72 weeks
measure: Urine protein creatinine ratio (UPCR)
timeFrame: Up to 72 weeks
measure: Graft and participant survival
timeFrame: Up to 72 weeks
measure: Percentage change from baseline in total IgG levels in serum over time
timeFrame: Up to 60 weeks
measure: Efgartigimod serum concentration-time profile and PK parameter Ctrough
timeFrame: Up to 48 weeks
measure: Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time
timeFrame: Up to 72 weeks
measure: Incidence of antibodies against rHuPH20 in plasma over time
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus
city: Gent
country: Belgium
facility: Universitair Ziekenhuis (UZ) Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
city: London
country: Canada
facility: London Health Sciences Centre
city: Praha
country: Czechia
facility: Institut klinicke a experimentalni mediciny (IKEM)
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
Study officials:
References: