Trial · NCT03608033

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

NCT03608033, Phase 3, Terminated, Omeros Corporation; results first posted 2025-12-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy. Trials, record NCT03608033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03608033

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
NCT number: NCT03608033
Status: Terminated
Phases: Phase 3
Enrollment: 360 participants, actual
Lead sponsor: Omeros Corporation
Conditions: IgA Nephropathy
Interventions: OMS721, Vehicle (D5W or saline)
First posted: 2018-07-31
Last updated: 2025-12-09
Results first posted: 2025-12-09

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in 24-hour UPE in g/Day Compared to Baseline	36 Weeks	The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.
Secondary	Change in Annualized eGFR Compared to Baseline.	96 Weeks	The Rate of Change in eGFR up to 96 Weeks from Baseline in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/Day)
Secondary	Change in Annualized eGFR Compared to Baseline in All Patients.	96 Weeks	The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE \> 1 g/Day)
Secondary	Change in 24-hour UPE in g/Day Compared to Baseline in All Patients	36 Weeks	Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE \> 1 g/Day)
Secondary	Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.	36 weeks and 48 weeks	Change From Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)
Secondary	Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).	36 weeks and 72 weeks	Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 72 Weeks in Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)
Secondary	Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients	36 weeks and 48 weeks	Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population
Secondary	Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients	36 weeks and 72 weeks	Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population
Secondary	Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs	Week 112	As assessed by the incidence of adverse events through study completion (Week 112) in the patient group in the all-patients population. Clinically meaningful abnormalities in vital signs, clinical laboratory tests, and ECGs were collected as AEs.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in 24-hour UPE in g/Day Compared to Baseline	36 Weeks	The prespecified Primary Interim Analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. The study was terminated after the Primary Analysis.	Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Change in Annualized eGFR Compared to Baseline.	96 Weeks	The prespecified secondary outcome analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.	mL/min/1.73 m²/year	MEAN
SECONDARY	Change in Annualized eGFR Compared to Baseline in All Patients.	96 Weeks	The prespecified secondary outcome analysis was in patients who had a 24-hour UPE \> 1 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.	mL/min/1.73 m²/year	MEAN
SECONDARY	Change in 24-hour UPE in g/Day Compared to Baseline in All Patients	36 Weeks	Outcome data for this secondary outcome measure are available for a subset of 260 of the 360 participants (132 OMS721 and 128 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on these measures could provide inaccurate and/or misleading information.	g/ 24hrs	MEAN
SECONDARY	Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.	36 weeks and 48 weeks	Outcome measure data for this secondary outcome measure are available for a subset of 131 of the 180 participants (66 OMS721 and 65 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.	g/24hr	MEAN
SECONDARY	Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).	36 weeks and 72 weeks	Outcome measure data for this secondary outcome measure are available for a subset of 121 of the 180 participants (60 OMS721 and 61 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.	g/24hr	MEAN
SECONDARY	Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients	36 weeks and 48 weeks	Outcome measure data for this secondary outcome measure are available for a subset of 229 of the 360 participants (118 OMS721 and 111 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.	g/24hr	MEAN
SECONDARY	Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients	36 weeks and 72 weeks	Outcome measure data for this secondary outcome measure are available for a subset of 203 of the 360 participants (103 OMS721 and 100 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.	g/24hr	MEAN
SECONDARY	Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs	Week 112	Any patient who received study drug (N=360)	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in 24-hour UPE in g/Day Compared to Baseline	OMS721	-21.3	Standard Error 0.0672	Percent Change
Percent Change in 24-hour UPE in g/Day Compared to Baseline	Placebo	-16.6	Standard Error 0.0680	Percent Change
Change in Annualized eGFR Compared to Baseline.	OMS721 (High Baseline Proteinuria Group)	-8.3	Standard Deviation 0.9	mL/min/1.73 m²/year
Change in Annualized eGFR Compared to Baseline.	Placebo (High Baseline Proteinuria Group)	-7.9	Standard Deviation 0.9	mL/min/1.73 m²/year
Change in Annualized eGFR Compared to Baseline in All Patients.	OMS721	-6.4	Standard Deviation 0.7	mL/min/1.73 m²/year
Change in Annualized eGFR Compared to Baseline in All Patients.	Placebo	-7.6	Standard Deviation 0.7	mL/min/1.73 m²/year
Change in 24-hour UPE in g/Day Compared to Baseline in All Patients	OMS721	-14.2	Standard Deviation 0.7	g/ 24hrs
Change in 24-hour UPE in g/Day Compared to Baseline in All Patients	Placebo	-10.3	Standard Deviation 0.6	g/ 24hrs
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.	OMS721 (High-risk Proteinuria Group)	4.1	Standard Deviation 0.5	g/24hr
Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.	Placebo (High-risk Proteinuria Group)	4.4	Standard Deviation 0.6	g/24hr

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	OMS721	181
Treatment Period	STARTED	Placebo	179
Treatment Period	COMPLETED	OMS721	37
Treatment Period	COMPLETED	Placebo	39
Treatment Period	NOT COMPLETED	OMS721	144
Treatment Period	NOT COMPLETED	Placebo	140
Open-Label Period: OMS721	STARTED	OMS721	34
Open-Label Period: OMS721	STARTED	Placebo	0
Open-Label Period: OMS721	COMPLETED	OMS721	15
Open-Label Period: OMS721	COMPLETED	Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events123

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	AE by System Organ	Blood and lymphatic system disorders	OMS721	13	181
other	AE by System Organ	Blood and lymphatic system disorders	Placebo	9	179
other	AE by System Organ	Blood and lymphatic system disorders	Open-Label OMS721	2	34
other	AE by System Organ	Cardiac disorders	OMS721	8	181
other	AE by System Organ	Cardiac disorders	Placebo	5	179
other	AE by System Organ	Cardiac disorders	Open-Label OMS721	2	34
other	AE by System Organ	Congenital, familial and genetic disorders	OMS721	0	181
other	AE by System Organ	Congenital, familial and genetic disorders	Placebo	2	179
other	AE by System Organ	Congenital, familial and genetic disorders	Open-Label OMS721	0	34
other	AE by System Organ	Endocrine disorders	OMS721	5	181

1 to 10 of 123Source ClinicalTrials.gov

See all 123 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OMS721	0	181
Total, all-cause mortality	Placebo	1	179
Total, all-cause mortality	Open-Label OMS721	0	34
Total, other adverse events	OMS721	137	181
Total, other adverse events	Placebo	121	179
Total, other adverse events	Open-Label OMS721	25	34
Total, serious adverse events	OMS721	22	181
Total, serious adverse events	Placebo	20	179
Total, serious adverse events	Open-Label OMS721	7	34

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35675911	DERIVED	PubMed
37772889	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
OMS721 vs Placebo: Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03608033

GET https://conductscience.org/api/trials/v1/NCT03608033/events?page=2

API reference For AI assistants