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OMS721 for Immunoglobulin A Nephropathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Omeros Investigational Site, Albuquerque, NMImmunoglobulin A NephropathyOMS721 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
BION-1301 Multiple Doses
1
Cefazolin 3gm for Injection USP and Dextrose Injection USP
1
Mezagitamab

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 168 Weeks

144 Weeks
Change from baseline in renal function as determined by the rate of change in estimated glomerular filtration rate (eGFR) up to 144 weeks from beginning of treatment
168 Weeks
Number of patients with treatment related Adverse Events as assessed by CTCAE v 4.0
36 Weeks
Change from baseline in 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment
Change from baseline in 24-hour urine protein excretion (UPE) in g/day at 36 weeks from beginning of treatment in the subset of patients with baseline high proteinuria (defined as 24-hour UPE ≥ 2 g/day)
Body Weight Changes

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
BION-1301 Multiple Doses
1
Cefazolin 3gm for Injection USP and Dextrose Injection USP
1
Mezagitamab

Trial Design

2 Treatment Groups

OMS721
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

450 Total Participants · 2 Treatment Groups

Primary Treatment: OMS721 · Has Placebo Group · Phase 3

OMS721
Biological
Experimental Group · 1 Intervention: OMS721 · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Vehicle (D5W or saline) · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Narsoplimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 168 weeks

Who is running the clinical trial?

Omeros CorporationLead Sponsor
23 Previous Clinical Trials
3,368 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Wisconsin100.0%
What site did they apply to?
Omeros Investigational Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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