Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
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
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
Treatments tested in this trial
- OMS906 study drug
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
6Lithuania
Omeros Investigational Site Kaunas Lithuania
Omeros Investigational Site Vilnius Lithuania
New Zealand
Omeros Investigational Site Auckland New Zealand
Poland
Omeros Investigational Site Lodz Poland
Sponsors and collaborators
Omeros Corporation
Lead sponsor
Source ClinicalTrials.gov