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
- Interventions
- Combination Product: Efgartigimod PH20 SC - prefilled syringeOther: Placebo PH20 SC - prefilled syringe
- Registration Number
- NCT06503731
- Lead Sponsor
- argenx
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
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:
- Received mycophenolate mofetil for at least 20 weeks before the study
- Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
- Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
- 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
The complete list of criteria can be found in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm 2 Placebo PH20 SC - prefilled syringe Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48 Treatment arm 1 Efgartigimod PH20 SC - prefilled syringe Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) Treatment arm 2 Efgartigimod PH20 SC - prefilled syringe Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48 Treatment arm 3 Placebo PH20 SC - prefilled syringe Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 78 weeks Percentage of participants with permanent treatment discontinuation due to adverse events (AEs) Up to 48 weeks
- Secondary Outcome Measures
Name Time Method Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time Up to 72 weeks Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR) Up to 72 weeks Urine protein creatinine ratio (UPCR) Up to 72 weeks Histological changes in kidney biopsy Up to 72 weeks Incidence of antibodies against rHuPH20 in plasma over time Up to 72 weeks Graft and participant survival Up to 72 weeks Percentage change from baseline in total IgG levels in serum over time Up to 60 weeks Efgartigimod serum concentration-time profile and PK parameter Ctrough Up to 48 weeks
Trial Locations
- Locations (13)
University of Alabama at Birmingham (UAB) Hospital
🇺🇸Birmingham, Alabama, United States
London Health Sciences Centre
🇨🇦London, Canada
Institut klinicke a experimentalni mediciny (IKEM)
🇨🇿Praha, Czech Republic
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil
🇫🇷Toulouse, France
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Hospital Del Mar
🇪🇸Barcelona, Spain
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus
🇦🇹Wien, Austria
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain