2023-508180-72-00RecruitingPhase 2
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.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Argenx
- Enrollment
- 25
- Locations
- 14
- Primary Endpoint
- Incidence and severity of Adverse Events (AEs)
Study Overview
Brief Summary
To evaluate the safety and tolerability of efgartigimod PH20 SC in kidney transplant recipients diagnosed with antibody-mediated rejection (AMR)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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 screening
- •The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of screening
- •A participant may be allowed into the study if they receive the following medications: a) Received mycophenolate mofetil (MMF) for ≥20 weeks before screening b) Has remained on a stable dose of mycophenolate mofetil (MMF) + tacrolimus (TAC) for ≥4 weeks before being allowed to participate in the study c) Has remained on tacrolimus (TAC) doses between 5 to 10 ng/mL ≥4 weeks before being allowed to participate in the study d) Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for ≥4 weeks before being allowed to participate in the study
Exclusion Criteria
- •Confirmed T-cell or mixed rejection at time of screening
- •Recent change in immunosuppressive therapy agents (more information is found in the protocol)
- •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
Outcomes
Primary Outcomes
Incidence and severity of Adverse Events (AEs)
Incidence and severity of Adverse Events (AEs)
Percentage of participants with permanent treatment discontinuation due to AEs
Percentage of participants with permanent treatment discontinuation due to AEs
Laboratory assessments, vital sign measurements, and ECG
Laboratory assessments, vital sign measurements, and ECG
Secondary Outcomes
- eGFR (absolute values and changes from baseline [slope])
- Histologic changes in kidney biopsy
- Urine Protein Creatinine Ratio
- Graft and participant survival
- Percentage change from baseline in total IgG levels in serum over time
- Efgartigimod serum concentration over time and PK parameter Ctrough
- Incidence and prevalence of antidrug antibody(ies) (ADA) against efgartigimod in serum over time
- Incidence and prevalence of antibodies against rHuPH20 in plasma over time
Investigators
Chief Scientific Officer
Scientific
Argenx
Study Sites (14)
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