RAINIER is a clinical research study for adults who have been diagnosed with IgA Nephropathy (IgAN) by kidney biopsy. This study is evaluating the safety and effectiveness of an investigational drug and how it might work to preserve kidney function.
Study participants may be able to join the study if they meet the following requirements:
18 years or older
Confirmed diagnosis of IgAN by biopsy
Stable doses of standard IgAN treatments (if prescribed)
Other study requirements will apply.
Study participation is a little longer than 2 years. You will attend in-person study visits to receive the study treatment and participate in study assessments each month. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Take the pre-screener to see if you may qualify!
Take the Pre-ScreenerThe investigational drug, povetacicept, is an injection received in the arm, thigh, or belly every 4 weeks. Povetacicept might protect the kidneys by blocking 2 proteins (BAFF and APRIL) that cause IgAN inflammation.
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You will be assigned at random to a study treatment (povetacicept or placebo). The placebo looks identical to povetacicept, but it does not contain any active ingredients. Placebos help researchers measure true effects of the investigational drug from perceived effects.
Investigational means the investigational drug is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like IgAN research (RAINIER Study).
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IgA nephropathy (IgAN) is an autoimmune disease where antibodies build up over time and can cause kidney damage.
IgAN may eventually lead to kidney failure and require dialysis or transplant. Although a cure for IgA nephropathy does not exist today, studies like RAINIER are actively researching potential investigational drugs and therapies to treat IgA nephropathy in diagnosed patients.
IgA nephropathy symptoms may not be noticed early in the disease course, but as the disease progresses patients can experience:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study objectives, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking an investigational treatment, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a clinical research study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions click here for more information on the RAINIER Study.
