Phase 2 Study of ManNAc for FSGS
This study is testing an oral drug called N-Acetyl-D-Mannosamine (ManNAc) for people with primary Focal Segmental Glomerulosclerosis (FSGS), a kidney disease that causes scarring and protein loss in the urine. Researchers want to see if ManNAc can reduce the amount of protein in your urine and if it is safe and well-tolerated over 12 weeks. You may be eligible if you are 18 years or older, weigh over 50 kg, and have a kidney biopsy showing FSGS from within the last 10 years. The study aims to enroll 30 participants. The current recruitment status is unclear.
- Study design
- This is a Phase 2, open-label study, meaning both you and the study team will know you are receiving ManNAc. It will involve 30 participants and is a single-arm study, so everyone receives the same treatment.
- What's involved
- You will have 5 to 6 clinic visits over 14 weeks, with two visits requiring overnight stays for 2 or 3 nights. You will take ManNAc, a white powder dissolved in water, by mouth twice a day for 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals for efficacy and safety are measured at 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- William A Gahl, M.D. · PRINCIPAL_INVESTIGATOR · National Human Genome Research Institute (NHGRI)
Who to contact
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What this trial measures
- Determine the efficacy of ManNAc therapy in reducing proteinuria (UPCR) in subjects with podocyte diseases.12-weeks.
- Assess the long-term safety and tolerability of orally administered ManNAc to subjects with podocyte diseases.12-weeks.