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Home / Managing RKD / Clinical Trials / A Sequential Phase 2/3 Study of Pegcetacoplan in Patients With Focal Segmental Glomerulosclerosis (FSGS)

A Sequential Phase 2/3 Study of Pegcetacoplan in Patients With Focal Segmental Glomerulosclerosis (FSGS)

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Brief Description

This is a sequential Phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of pegcetacoplan in patients diagnosed with FSGS. Currently, only Phase 2 is enrolling. The Phase 2 is a single-arm, open-label study that is 2 years in length

Trial Physician / Study Coordinator

Oscar Lemus

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Estimated Enrollment

2-4 patients/year

Estimated End Date

Not Available at this stage of the study

Trial is for people with

A history of primary, genetic, or undetermined-cause FSGS diagnosed by biopsy for Phase 2 enrollment. Patients must be receiving ...

Study Goal

To see if pegcetacoplan added to current therapy can reduce and normalize proteinuria and slow the decline of kidney function, and to ...

What is involved for the patient?

After completing screening, eligible patients will receive study drug for up to 2 years. Patients/caregivers will be trained to ...

About the drug or intervention

Pegcetacoplan works by decreasing the activity of the complement system, which is part of the immune system and can be overactive in ...

Find other locations for this trial:
Los Angeles, CA

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Did you have a biopsy to confirm your diagnosis?*
Are you currently on the transplant wait-list?*
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Disclaimer

By clicking the submit button, your information and results will be sent to the study coordinator. Submitting the form does not guarantee enrollment but helps determine potential eligibility and connects you with the study team. Please consult your healthcare provider before pursuing participation in any trial.

Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

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Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

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Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.

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