Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)
ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovelMed Therapeutics
About this trial
This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.
Eligibility criteria
Qualifiers
Male and female patients ≥18 years of age at the time of consent.
A body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2.
Confirmation of IgA Nephropathy verified by biopsy performed within the previous three years.
All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135. MenB meningococcal serogroup B vaccine (Bexsero®) will be administered per local guidelines.
Disqualifiers
Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with NM8074.
Require dialysis or plasma exchange within 12 weeks prior to screening.
Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy.
History of bone marrow, hematopoietic stem cells, or solid organ transplantation.
Trial design
Treatments tested in this trial
- NM8074
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov