EAP: Pegcetacoplan (C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis) - Clinical Trial
What is the 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.
What is the Condition Being Studied?
C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Who Can Participate in the Study?
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
For more information, contact the study team at vmp19@duke.edu.
Age Group
Adults
What is Involved?
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
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
IRB:
PRO00116657
NCT:
NCT04729062
Phase
Phase
N/A
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment