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Monoclonal Antibodies
Sibeprenlimab for IgA Nephropathy
Phase 3
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 24 months
Awards & highlights
Study Summary
This trial will study whether sibeprenlimab can help improve proteinuria and glomerular filtration rate in adults with IgAN who are already receiving the best available standard care.
Who is the study for?
Adults with IgA Nephropathy (IgAN) who've been on a stable dose of certain kidney medications for at least 3 months can join. They need to have a specific level of protein in their urine and their kidneys must be functioning above a certain threshold. People with other kidney diseases, uncontrolled diabetes or hypertension, or those on recent immunosuppressants can't participate.Check my eligibility
What is being tested?
The trial is testing Sibeprenlimab, given as an injection every four weeks, against a placebo. Participants also continue their usual care for IgAN. The study aims to see if Sibeprenlimab helps reduce protein in the urine and affects kidney function over time.See study design
What are the potential side effects?
Potential side effects of Sibeprenlimab are not detailed here but may include reactions similar to other immune-modulating drugs such as injection site reactions, increased risk of infections, and possible impacts on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Secondary outcome measures
Annualized rate of change from baseline (slope) of eGFR
Annualized slope of eGFR
Proportion of subjects achieving urine total protein < 1.0 g/day and ≥ 25% reduction from baseline.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Sibeprenlimab 400 mg s.c. q 4weeksActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,465 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of heart medication for at least 3 months.I have not taken part in another drug trial within the last 30 days or 5 half-lives of the drug.I have not taken immunosuppressants, including steroids, in the last 16 weeks.I have been diagnosed with nephrotic syndrome.My high blood pressure is not under control.I am 18 years old or older.I have IgA nephropathy confirmed by a biopsy.The amount of protein in your urine is too high.I have Type 1 diabetes or my Type 2 diabetes is not well-controlled.Your blood test shows low levels of IgG antibodies.I have chronic kidney disease, but it's not IgA nephropathy.I have a long-term infection or a current infection.Your kidney function, measured using a special equation, is at a certain level. If it's too low, you may not be able to participate in the study.My kidney biopsy shows specific damage levels according to the Oxford classification.My kidney biopsy shows IgAN and may include other conditions like diabetic kidney disease.My condition is related to IgA nephropathy or IgA vasculitis.
Research Study Groups:
This trial has the following groups:- Group 1: Sibeprenlimab 400 mg s.c. q 4weeks
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being accepted for this clinical trial at this time?
"That is accurate. As of now, the online clinicaltrials.gov registry shows that the470 people are needed for the study at a single site. The study was first posted on March 11th, 2022 and last updated on March 25th, 2022."
Answered by AI
Are there any 400 mg s.c. q 4weeks Sibeprenlimab dosage dangers patients should be aware of?
"Sibeprenlimab 400 mg s.c. q 4weeks, a medication used in this phase 3 trial, is estimated to be safe based on prior data supporting its efficacy and multiple rounds of safety testing."
Answered by AI
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