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Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
RAINIER
RAINIER
Brief Description
RAINIER is a clinical research study for adults with immunoglobulin A nephropathy (IgAN).
Trial Physician / Study Coordinator
Helen Thomas
Email
Phone
Site Name
Bioluminux Clinical Research- New Jersey
2132 NJ-33 Hamilton NJ 08690
Sponsor
Vertex Pharmaceuticals
Study Drug
Povetacicept
Estimated enrollment
480
Estimated end date
May 29th, 2026
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
RAINIER
RAINIER
Brief Description
RAINIER is a clinical research study for adults with immunoglobulin A nephropathy (IgAN).
Trial is for people with
immunoglobulin A nephropathy (IgAN)
Study Goal
This study is measuring the safety and effectiveness of the study drug compared to placebo in participants with IgA nephropathy.
What is involved for the Patient?
Study participation is a little longer than 2 years. Study Participants will attend in-person study visits to receive the study treatment and participate in study assessments every 4 weeks. Study participants can expect the following:
a. Screening Period (up to 6 weeks): You will receive study health assessments to confirm if you qualify for the study. These assessments include physical exam, medical history review, electrocardiogram (ECG), vital signs, blood tests, and urine tests.
b. Study Treatment Period (Every 4 weeks over 2 Years): Participants are assigned at random to receive study treatment with either povetacicept (the investigational drug) or placebo. The placebo looks identical to povetacicept but does not have active ingredients. You will receive an injection of your assigned study treatment every 4 weeks for a total of 26 doses.
c. Follow-up Period (12 Weeks): Your final study assessment will be 12 weeks after your last dose.
About the drug or intervention
The study drug is an injection given once every 4 weeks just under the skin in the arm, thigh, or belly. It might block 2 proteins (BAFF and APRIL) that contribute to kidney inflammation from IgAN.
