Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of OMS721 (narsoplimab) in subjects with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 (C3) Glomerulopathy including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of OMS721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of Asian descent with IgA Nephropathy.

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Detailed Description

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Conditions

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IgAN Lupus Nephritis MN C3 Glomerulopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cohort 2 and 3 subjects are randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 are non-randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OMS721 (narsoplimab)

Administration of OMS721 (narsoplimab)

Group Type EXPERIMENTAL

OMS721 (narsoplimab)

Intervention Type BIOLOGICAL

Biological: OMS721 (narsoplimab)

Interventions

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OMS721 (narsoplimab)

Biological: OMS721 (narsoplimab)

Intervention Type BIOLOGICAL

Other Intervention Names

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narsoplimab

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age at screening and competent to provide informed consent; For Cohort 4 only, participants are of Asian descent
* Have a diagnosis of one of the following:

1. IgAN on kidney biopsy
2. LN, MN and C3 Glomerulopathy including Dense Deposit Disease on kidney biopsy and 24-hour Urine Protein Excretion (UPE) \> 1000 mg/24 hours (for Cohort 1 only)
3. IgAN diagnosis is confirmed by biopsy within 8 years of screening for Asian descent (for Cohort 4 only)
* For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hour UPE \> 1 g within 6 months prior to Screening or Urine Protein-Creatinine Ratio (uPCR) \> 0.75 by spot urine at screening
* Screening Estimated Glomerular Filtration Rate (eGFR) \>= 30 mL/min/1.73 m\^2
* Are on physician-directed, stable, optimized treatment with angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have a systolic blood pressure of \< 150 mmHg and a diastolic blood pressure of \< 90 mmHg at rest

Exclusion Criteria

* Have a hemoglobin less than 9.0 g/dL
* Have a platelet count =less than 100,000/mm\^3
* Have an absolute neutrophil count \<500 cells/mm\^3
* Have an Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) greater than 5.0 x the upper limit of normal (ULN)
* Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior to Screening
* Have used: belimumab, eculizumab, or rituximab within 6 months prior to Screening
* Have a history of renal transplant
* History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody
* Have a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for 5 years or more

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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