Purpose of this Study
We are doing this study to be an early access program to treat C3G or IC-MPGN, which may lead to damage in your kidneys, protein in your urine, high blood pressure, and swelling of your hands, feet, and ankles.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with primary C3G or IC-MPGN or recurrence after transplant
- Have documented renal (kidney) disease
- Have a limited or no response to other treatments for C3G/IC-MPGN
- Are vaccinated against pneumonia, meningitis, and the flu
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Have pegcetacoplan prescribed as treatment for your condition
- Be trained on how to inject the drug at home (we can teach your caregiver as well)
- Return to our clinic every 3 months for tests to see how you are doing
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
US EARLY ACCESS PROGRAM FOR THE TREATMENT OF PATIENTS WITH C3 GLOMERULOPATHY OR PRIMARY IMMUNE-COMPLEX MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS WITH PEGCETACOPLAN
Principal Investigator
Rasha
Raslan
Protocol Number
PRO00116657
NCT ID
NCT04729062
Phase
N/A
Enrollment Status
Open to Enrollment