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Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN

ConditionsC3 GlomerulopathyIdiopathic Immune Complex-Mediated Glomerulonephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOmeros Corporation

About this trial

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female adults 18 years and older.

Competent to provide informed consent and has completed informed consent procedures.

Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.

Two 24-hour UPCR ≥ 0.8 gm/gm with the 2 collections separated by 14 - 28 days.

Disqualifiers

History of major organ transplant or hematopoietic stem cell/marrow transplant.

Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.

Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.

Have renal biopsy findings showing interstitial fibrosis/tubular atrophy of more than 50%.

Trial design

Design model

Single group

Treatments tested in this trial

  • OMS906 study drug

    Drug

    OMS906 study drug dose 5mg/kg IV administration at 4-week internals

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Study Drug OMS906Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN.

Number of participants with Adverse Events following dosing of OMS906.

Time frame
48 weeks

Secondary outcomes

1

Change in proteinuria measured by 24-hour urine protein/creatinine ratio (UPCR).

Change from baseline in proteinuria measured as 24-hour UPCR at 12, 24, and 48 weeks.

Time frame
12, 24, 48 weeks
2

Change in proteinuria measured by 24-hour urine protein excretion (UPE).

Change from baseline in proteinuria measured as 24-hour UPE at 12, 24, and 48 weeks.

Time frame
12, 24, and 48 weeks.
3

Change in proteinuria measured as 24-hour urine albumin excretion (UAE).

Change from baseline in proteinuria measured as 24-hour UAE at 12, 24, and 48 weeks.

Time frame
Time Frame: 12, 24, and 48 weeks.
4

Change in proteinuria measured as 24-hour urine albumin/creatinine ratio (UACR).

Change from baseline in proteinuria measured as 24-hour UACR at 12, 24, and 48 weeks.

Time frame
12, 24, and 48 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Omeros Corporation

Lead sponsor

Source ClinicalTrials.gov
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