Phase 2Recruiting
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
- Sponsor
- National Human Genome Research Institute (NHGRI) (NIH)
- Enrolment
- 30 planned
- Conditions
- Focal Segmental Glomerulosclerosis; Minimal Change Disease; Membranous Nephropathy
- Interventions
- ManNAc
- Ages
- adults, older adults
- Registry
- NCT06664814
From the registry
Background: Podocyte diseases are a group of kidney conditions that include focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), and membranous nephropathy (MN). In these conditions, specialized kidney cells called podocytes, which help prevent protein from leaking into the urine, are damaged. This can result in high levels of protein in the urine and, over time, worsening kidney function. In some people, the disease may progress to kidney failure requiring dialysis or a kidney transplant. Several treatments are currently available and can be beneficial, but they may cause significant side effects and may not work well for everyone. Therefore, there is a need for safer and more effective treatments for people with these types of kidney conditions. Objective: To test a study drug (ManNAc) in people with a podocyte disease, that includes Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), or Membranous Nephropathy (MN). Eligibility: People aged 18 years and older with a podocyte disease, that includes Focal Segmental Glomerulosclerosis…
Primary outcomes
- Determine the efficacy of ManNAc therapy in reducing proteinuria (UPCR) in subjects with podocyte diseases.
- Assess the long-term safety and tolerability of orally administered ManNAc to subjects with podocyte diseases.