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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 below
Select...
I completed a specific trial without safety issues and might benefit from sibeprenlimab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 and 24 months for reporting.

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 more

Trial 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

Sibeprenlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05248659 — Phase 2 & 3
IgA Nephropathy Research Study Groups: Sibeprenlimab 400 mg s.c. q 4 weeks
IgA Nephropathy Clinical Trial 2023: Sibeprenlimab Highlights & Side Effects. Trial Name: NCT05248659 — Phase 2 & 3
Sibeprenlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05248659 — Phase 2 & 3

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"

Answered by AI
~400 spots leftby Dec 2028