Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

Find a Research Study

A Study to Test if Atacicept is Safe and Works in Autoimmune Kidney Diseases

This study wants to learn if a new drug called atacicept can help protect the kidneys and reduce kidney damage in people with multiple autoimmune kidney diseases.


Why this Research Matters

Some autoimmune kidney diseases, such as Immunoglobulin A (IgA) nephropathy, IgA vasculitis with nephritis, primary membranous nephropathy, minimal change disease, and focal segmental glomerulosclerosis, can hurt the kidneys. These diseases cause the immune system to attack kidney filters. This can lead to protein leaking into the urine and cause the kidneys to lose function over time. New treatments are needed to help protect the kidneys and slow this damage. This study is testing a new drug called atacicept. Atacicept may help lower harmful antibodies that harm the kidneys. Atacicept is not approved by the U.S. Food and Drug Administration (FDA). If you join this study, you will first have a screening period to see if you are able to join. This period lasts about 4 weeks. During this time, you will come in person for tests. These tests include a physical exam, blood and urine tests, heart testing, and questions about your health and medications you may take. If you are able to join, you will then enter the treatment period. This period will last up to 12 months. You will have about 11 study visits. At these visits, the study team will check your health, collect blood and urine samples, and ask about symptoms and medications you may be taking. You will also fill out surveys about your health and daily life. In between these visits, you will give yourself one shot of the study drug, just under the skin, once a week for about 9 months and record information about your health. After the treatment period ends, you will have 2 follow up visits over about 6 months. The study team will check your health and see how the study drug may have affected your kidneys. Your total time in the study will be about 18 months. You will be paid $100 for each visit you complete. You may also be paid back for travel costs, such as mileage, parking, or other travel costs.


Who can Participate

Adult

You may be able to join this study if you are 18 years old or older and have an autoimmune kidney disease. Such as, IgA nephropathy, IgA vasculitis with nephritis, primary membranous nephropathy, minimal change disease, or focal segmental glomerular sclerosis. You must weigh at least 40kg (about 88 pounds). Your blood pressure must be stable. Both men and women must use birth control methods while in the study. You cannot join if you are pregnant or plan to become pregnant. You cannot be on dialysis. You cannot join if you have certain health problems. Such as, uncontrolled diabetes, tuberculosis, HIV, hepatitis B, or hepatitis C. You also cannot join if you have multiple sclerosis, optic neuritis, bad heart problems, or if your spleen was removed. You also cannot join if you had cancer in the past 5 years, except for some treated skin cancers and cervical cancer. You cannot join if you had drug or alcohol abuse in the past year.


Study ID

Protocol Number: 25-1324


Compensation Information

Compensation
Study Payment: Compensation provided.

Meet the Team

Image of Principal Investigator

James Dylewski

Principal Investigator