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Monoclonal Antibodies

OMS721 for Immunoglobulin A Nephropathy

Phase 3
Waitlist Available
Research Sponsored by Omeros Corporation
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 36 and 72 weeks
Awards & highlights

Study Summary

This trial will study the drug OMS721 in patients with IgA nephropathy to see if it is safe and effective. The study will look at how much protein is in the urine after 36 weeks of treatment.

Eligible Conditions
  • Immunoglobulin A Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 and 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in 24-hour UPE in IgA nephropathy (IgAN) patients assessed at 36 weeks from baseline
Secondary outcome measures
Assessment of percentage of participants with presence of neutralizing antibodies
Assessment of pharmacodynamics of narsoplimab intravenous infusion
Assessment of pharmacodynamics of narsoplimab intravenous infusion with presence of positive anti-drug antibodies
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OMS721Experimental Treatment1 Intervention
Administration of OMS721
Group II: PlaceboPlacebo Group1 Intervention
Administration of Vehicle (D5W or Saline Solution)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Narsoplimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Omeros CorporationLead Sponsor
28 Previous Clinical Trials
3,447 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other research teams attempted anything like this previously?

"Currently, there are 2 ongoing studies for OMS721 across 10 countries and 45 cities. The earliest study was completed in 2018 by 450 participants.Sponsored by Omeros Corporation, this trial reached Phase 3 drug approval and 1 more trials have been conducted since then."

Answered by AI

What is the maximum number of patients who can enroll in this trial?

"That is correct. The information available on clinicaltrials.gov reveals that this particular trial is still recruiting patients. This specific study was originally posted on February 16th, 2018 and was most recently updated on May 28th, 2019. In total, they are looking for 450 participants spread out over 21 different locations."

Answered by AI

Are researchers actively seeking participants for this trial?

"That is correct, the information available on clinicaltrials.gov reveals that this particular trial is looking for new patients. This specific trial was created on 2/16/2018 and updated as recently as 5/28/2019. In total, they are seeking 450 participants from 21 different locations."

Answered by AI

Are there several sites running this trial in the city?

"To make things as convenient as possible for the patients, this clinical trial is enrolling at 21 locations. These medical centres are situated in Albuquerque, Minneapolis, Columbus and 18 other cities. Consequently, when deciding whether or not to participate, please consider how close the sites are to your residence."

Answered by AI

Are there any life-threatening risks associated with OMS721?

"OMS721 is in Phase 3 of clinical trials, so there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

What is the history of research on OMS721?

"There are two ongoing clinical trials researching the efficacy of OMS721. One of these live studies is in Phase 3. The majority of research for this treatment is being conducted in Vilnius and Washington, but there are 60 total locations running trials."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
What site did they apply to?
Omeros Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
~50 spots leftby Mar 2025