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Currently Enrolling
1

Atacicept for IgAN Patients

A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

Brief Description

This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that treatment with atacicept will reduce proteinuria compared to placebo.

Trial Physician / Study Coordinator

US Medical Information ; Merck KGaA Communication Center

Email Phone
Site Name

Research Site

Sponsor

EMD Serono Research & Development Institute, Inc.

Study Drug

Atacicept

Estimated enrollment

30

Estimated end date

June, 2021

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Find other locations for this trial:
Currently Enrolling
1

Atacicept for IgAN Patients

A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy

Brief Description

This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that treatment with atacicept will reduce proteinuria compared to placebo.

Trial is for people with

IgA Nephropathy

Study Goal

To determine if Atacicept is well tolerated by IgAN patients and effective at reducing proteinuria.

What is involved for the Patient?

Patients will receive the study drug weekly as a subcutaneous injection for 72 weeks.

About the drug or intervention

Atacicept inhibits the function of specific cells of the immune system.

Find other locations for this trial:
Columbus, OH
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.

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.

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.

See other frequently asked questions