← Back to Search

Checkpoint Inhibitor

Sibeprenlimab for IgA Nephropathy

Phase 2
Recruiting
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be at least 16 years of age or older at the time of signing the informed consent/assent
Participant has estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration [CKD EPI] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 [CKiD U25] eGFR equation for those younger than 18 years)
Must not have
Participant has coexisting chronic kidney disease, other than IgAN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the effects of a drug called sibeprenlimab on a kidney disease called immunoglobulin A nephropathy (IgAN) by looking at specific markers in

Who is the study for?
This trial is for individuals at least 16 years old with a confirmed diagnosis of IgA Nephropathy and a kidney function (eGFR) above 45 mL/min/1.73 m2. It's not for those with other chronic kidney diseases, low serum IgG levels, uncontrolled high blood pressure, pregnant or breastfeeding women, or anyone who has used systemic corticosteroids or immunosuppressants within the last 24 weeks.
What is being tested?
The trial studies Sibeprenlimab's effects on kidney tissue in patients with IgA Nephropathy. As an open-label phase 2b study, it aims to identify disease biomarkers and observe changes after treatment without hiding which participants receive the drug.
What are the potential side effects?
While specific side effects of Sibeprenlimab are not listed here, similar drugs can cause immune system reactions, infections risk increase, potential liver issues and may affect blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 16 years old or older.
Select...
My kidney function, measured by eGFR, is above 45 mL/min/1.73 m2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chronic kidney disease not caused by IgA nephropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SibeprenlimabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
266 Previous Clinical Trials
169,087 Total Patients Enrolled
2 Trials studying Immunoglobulin A Nephropathy
1,130 Patients Enrolled for Immunoglobulin A Nephropathy
~17 spots leftby Apr 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top