Study of NM8074 in Adult C3 Glomerulopathy Patients
ConditionC3 Glomerulopathy
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovelMed Therapeutics
About this trial
This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.
Eligibility criteria
Qualifiers
Patients ≥ 18 and ≤ 65 years at the time of consent
Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment
Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening
Patients with confirmed proteinuria
Disqualifiers
Use of other investigational drugs at the time of enrollment
Patients with other renal diseases that would interfere with interpretation of the study
Estimated glomerular filtration rate of ≤ 20 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening
Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (xULN)
Trial design
Treatments tested in this trial
- NM8074
Treatment groups
18 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov