Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
NOBLE
Phase II Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G (Complement 3 glomerulopathy) or IC-MPGN (immune-complex membranoproliferative glomerulonephritis)
Brief Description
The study is evaluating the safety and effectiveness of an investigational, targeted C3 inhibitor called pegcetacoplan in adults who have C3G or IC-MPGN recurrence after kidney transplant
Trial Physician / Study Coordinator
Elizabeth Carfioli
EmailSite Name
Nijmegen, Netherlands
Sponsor
APELLIS Pharmaceuticals, Inc.
Study Drug
Pegcetacoplan
Estimated enrollment
12 patients
Estimated end date
End of enrollment – December 2021; End of study – September 2022
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
NOBLE
Phase II Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G (Complement 3 glomerulopathy) or IC-MPGN (immune-complex membranoproliferative glomerulonephritis)
Brief Description
The study is evaluating the safety and effectiveness of an investigational, targeted C3 inhibitor called pegcetacoplan in adults who have C3G or IC-MPGN recurrence after kidney transplant
Trial is for people with
Diagnosis of C3G or IC-MPGN that has recurred after a kidney transplant. In addition, participants must be:
- at least 18 years of age
- willing to use contraception during the study, and for 90 days after the last dose of the investigational medication
Study Goal
The NOBLE study is exploring whether pegcetacoplan has an effect on the build up of the complement protein C3 in the kidney, that causes kidney damage.
What is involved for the Patient?
After completing a screening period, study participants will be randomly assigned (randomized) to one of two treatment groups:
o Group 1: Will receive pegcetacoplan, for the entire duration of the study (up to 1 year). There is a 3 in 4 (75%) chance of being assigned to this group.
o Group 2: Will continue their current treatment for the first 12 weeks (3 months) of the study and then transition to receive pegcetacoplan for the remaining 40 weeks (9 months) of the study. There is a 1 in 4 (25%) chance of being assigned to this group.
o While study participants will know their treatment group assignment, they will not have the option of choosing their group.
• Study participants who complete the 1-year study treatment period and are experiencing a benefit may enter a long-term extension study where they will continue receiving pegcetacoplan. Otherwise, they will enter an 8-week follow-up period after their last dose of investigational medication.
• There are approximately 14 clinic visits during the 1-year study treatment period and 3 visits during the 8-week follow-up period. Reimbursement or pre-paid travel support may be available to study participants.
• In addition to having study procedures at study visits, participants will regularly complete urine collections at home during the study.
About the drug or intervention
Pegcetacoplan is an investigational, targeted C3 inhibitor. It is administered via a needle, under the skin (subcutaneous), twice weekly at home. Investigational means that pegcetacoplan is not approved by any health authority for the treatment of C3G or MPGN.