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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508180-72-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm 1 | Experimental | Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
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| Treatment arm 2 | Experimental | 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 Comparator | Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod PH20 SC - prefilled syringe | Combination Product | Subcutaneous efgartigimod PH20 SC given by prefilled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR) | Up to 72 weeks | |
| Histological changes in kidney biopsy | Up to 72 weeks | |
| Urine protein creatinine ratio (UPCR) |
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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:
Exclusion Criteria:
The complete list of criteria can be found in the protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35233 | United States | ||
| Cedars-Sinai Medical Center |
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| Placebo PH20 SC - prefilled syringe | Other | Subcutaneous placebo PH20 SC given by prefilled syringe |
|
| Up to 72 weeks |
| Graft and participant survival | Up to 72 weeks |
| Proportion of participants with biopsy-proven histologic resolution (BPHR) over time | Up to 72 weeks |
| Changes from baseline in AMR/MVI index score over time | MVI: microvascular inflammation. AMR/MVI score is a continuous index derived from Banff histological lesions (g, ptc, cg, and C4d positivity) and used to quantify the intensity of microvascular inflammation linked to AMR. It aims to describe where a biopsy lies along the spectrum from no rejection to probable AMR to complete AMR/MVI, providing a more granular measure of disease severity than dichotomous Banff categories. | 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 |
| Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time | Up to 72 weeks |
| Incidence of antibodies against rHuPH20 in plasma over time | Up to 72 weeks |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60615 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
| 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 |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus | Vienna | 1090 | Austria |
| Universitair Ziekenhuis (UZ) Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg | Leuven | 3000 | Belgium |
| London Health Sciences Centre | London | N6A 5A5 | Canada |
| Institut klinicke a experimentalni mediciny (IKEM) | Prague | 140-21 | Czechia |
| Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin | Bordeaux | 33076 | France |
| Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon | La Tronche | 38700 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil | Toulouse | 31059 | France |
| Charité - Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |