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Home / Managing RKD / Clinical Trials / VALIANT

VALIANT

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Brief Description

The purpose of this study is to assess the efficacy and safety of twice weekly pegcetacoplan compared to placebo in patients with C3G or IC-MPGN, on the basis of a reduction in urinary protein levels.

Estimated Enrollment

Approximately 90

Estimated End Date

March 2025

Trial is for people with

Confirmed C3G or IC-MPGN, with or without prior renal transplantation. In addition, participants must: • Be at least 12 years old ...

Study Goal

The VALIANT study will assess whether pegcetacoplan, an investigational targeted C3 inhibitor, has an effect on the damage to kidney ...

What is involved for the patient?

After completing the screening period to confirm that the patient is able to participate in the study, individuals will be randomly ...

About the drug or intervention

Pegcetacoplan is an investigational, targeted C3 inhibitor. It is administered via a needle, under the skin (subcutaneous), twice ...

Find other locations for this trial:
Rome, Italy

I'm Interested in this Trial

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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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