Participation in this study is expected to last for approximately 18 months (1.5 years) after completing the screening period and may be followed by a long-term extension study.
- Study participants will be randomly assigned (randomised) to either receive the investigational medication, pegcetacoplan, from the beginning of the 1-year study treatment period, or to continue their current treatment for 3 months before transitioning to receive pegcetacoplan for the remainder of the study treatment period. There is a 75% chance of receiving pegcetacoplan from the start of the study treatment period.
- Study participants who are benefiting medically from the investigational medication may be able to participate in a long-term extension study after completing the 1-year study treatment period, where they will continue receiving pegcetacoplan.
- There are approximately 14 in-clinic visits during the 1-year study treatment period and 6 visits during the 6-month follow-up period after last dose of the investigational medication.
- Participants who enter the long-term extension study, will have in-clinic visits approximately every 3 months.
To participate, you must:
- Be at least 18 years old
- Have had a kidney transplant
- Be experiencing a recurrence of C3G or MPGN in the transplanted kidney, confirmed by a kidney biopsy. The kidney biopsy may be done as part of the study
- Have significant proteinuria (protein in the urine) confirmed by 24-hour urine collection during the screening process
- Have normal to moderately impaired kidney function as indicated by estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
- Be willing to use contraception until at least 3 months after the last dose of investigational medication
Additional criteria will be assessed at the research site to confirm eligibility.
All study-related procedures, including study-required kidney biopsies, and investigational medication will be provided to study participants at no cost. Transport to and from study visits, or reimbursement for travel-related costs may be available to study participants.
Investigational means that pegcetacoplan is not approved by any health authority for the treatment of C3G or MPGN. Talk to your doctor if you are interested in a clinical trial.
To learn more, and to connect with a participating clinical trial site, email clinicaltrials@apellis.com or visit theNOBLEstudy.com.