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Monoclonal Antibodies
Sibeprenlimab for IgA Nephropathy
Phase 2 & 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
Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 24 months
Awards & highlights
Study Summary
This trial is testing a new drug for IgA Nephropathy, a kidney disease. The drug is given as a shot and the goal is to see if it is safe and effective.
Who is the study for?
This trial is for people with a kidney condition called IgA Nephropathy who have a certain level of kidney function (eGFR ≥ 20 mL/min/1.73 m2) and completed previous trials without safety issues. It's not open to those who didn't finish the earlier studies or developed conditions that would have excluded them.Check my eligibility
What is being tested?
The study tests Sibeprenlimab, given as an injection under the skin every four weeks, to see how safe and effective it is over time for treating IgA Nephropathy.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to Sibeprenlimab since assessing long-term safety and tolerability is one of the main goals of this phase.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I completed a specific trial without safety issues and might benefit from sibeprenlimab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Annualized slope of Estimated Glomerular Filtration Rate (eGFR)
Proportion of Subjects with Clinical Remission as defined in the protocol
Chronic Kidney Diseases
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Sibeprenlimab 400 mg s.c. q 4 weeksExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
245 Previous Clinical Trials
166,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I completed a specific trial without safety issues and might benefit from sibeprenlimab.Your kidney function, as measured by eGFR, is at least 20 mL/min/1.73 m2.You developed a condition after participating in previous trials that would have kept you from joining this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Sibeprenlimab 400 mg s.c. q 4 weeks
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 researchers looking for more people to test this medication?
"No, this particular trial is not looking for any more participants. Although, there are 502 other trials with open recruitment at the moment. This specific study was posted on March 1st, 2022 and last updated February 18th, 2022 according to clinicaltrials.gov"
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