What is the purpose of the ORIGIN study?
The ORIGIN study is an IgA Nephropathy study that will measure the effectiveness of the study medication, atacicept, at improving kidney function to prevent further kidney damage in people with IgAN. An early clinical study with atacicept showed potential benefit for IgAN patients, including the reduction of Gd-IgA1 that is believed to be the source of the disease. However, more clinical data is needed to validate the effect of the study medication.
How long will the study last?
If you join the study, your participation will last for about 2 and a half years total. More information about what to expect during that time can be found below.
Who can participate in the ORIGIN study?
You may be able to participate in the ORIGIN study if you meet the following requirements:
- You are 18 years of age or older, or you meet your country’s legal adult age
- You have been diagnosed with IgA Nephropathy, confirmed by a kidney biopsy within the past 10 years
- You are on a stable, prescribed regimen of an RAASi (for example, ACE/ARB) medication for at least 12 weeks
Other requirements will apply.
Where is the ORIGIN study being conducted?
The ORIGIN study is being conducted across the world including the US, Europe and Asia-Pacific regions. To make it easier on people with IgAN, the study also allows some study visits to be conducted at home if you and the study doctor determine that it is acceptable. Additionally, there may be reimbursement and support for travel assistance for study visits.
What will happen during the study?
Screening Period (up to 4 weeks)
The Screening Period helps determine if you qualify for the study.
During Screening, you will visit the study clinic and complete health assessments, like a physical exam, urine test, and blood test. You may also receive a kidney biopsy to confirm your IgAN diagnosis if you have not had a biopsy within the past 10 years.
Blinded Dosing Period (36 weeks)
During this period, you can expect the following:
- Be randomly assigned to receive a weekly injection of either the study medication or placebo. You have about a 70% chance of being assigned the study medication, and neither you nor the study staff will know your assignment
- Receive your first injection of the study medication or placebo at the study clinic. Study staff will provide instructions on how you or a caregiver will give the weekly injections of the study medication while at home
- Visit the study clinic regularly for assessments, similar to those completed during Screening. These assessments help the study team determine how your body is reacting to the study medication
- An important regular assessment to understand your kidney function is the collection of urine in a container within a 24 hour period. The study team will provide appropriate supplies and instructions to collect 24 hour urine during the study.
Open-Label Extension Period (60 weeks)
About 36 weeks (9 months) after your first dose of the study medication or placebo, all participants will receive the study medication for an additional 60 weeks (15 months).
You will continue to visit the study clinic regularly for assessments during this period. Some study visits may be conducted remotely.
Safety Follow-up Period (26 weeks)
After your last dose of the study medication, you will attend 2 follow-up visits at the study clinic. During these visits, you will complete assessments similar to others received during the study.
Your final follow-up visit completes your participation in the ORIGIN study.