At a glance
ClinicalIndex Comparison Record- ✓Prior kidney biopsy demonstrating FSGS obtained within 10 years prior to the screening visit
- ✓Age ≥18 years weighing more than 50 kg
- ✓Immunosuppressive therapy stable for ≥3 months prior to study evaluation and ≥4 weeks at stable dose before trial start
- ✓Standard of care non-immunosuppressant antiproteinuric agents at stable dose for ≥4 weeks before trial start
- ✕Unwilling or unable to provide informed consent
- ✕Uncontrolled nephrotic syndrome with proteinuria >3g/g or >3.5g/day with symptomatic edema, pulmonary edema, hypoalbuminemia, electrolyte disturbances, or active thromboembolism
- ✕Requiring acute optimization of volume status with intravenous diuretics
- ✕Psychiatric illness or neurological disease interfering with protocol adherence
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis
In Brief
A Phase 2 clinical trial evaluating ManNAc for Focal Segmental Glomerulosclerosis. Currently recruiting, targeting 30 participants across 1 site.
Detailed Summary
Background: Focal segmental glomerulosclerosis (FSGS) is a disease that causes scarring in parts of the kidneys that filter waste. This can lead to protein loss in the urine, which can worsen kidney function. The kidneys may fail over time, and dialysis or a kidney transplant may be needed. Other treatments for this disease do not always work and often have adverse effects. Better treatments for FSGS are needed. Objective: To test a study drug (ManNAc) in people with FSGS. Eligibility: People aged 18 years and older with FSGS. Design: Participants will have 5 to 6 clinic visits over 14 weeks. Two of the visits will require overnight stays for 2 or 3 nights. ManNAc is a white powder that comes in a sachet. It is dissolved in water and taken twice a day by mouth. Participants will take their first dose at the clinic. They will learn how to store ManNAc and prepare each dose. They will record their doses in a diary. They will also write down any adverse effects or troubles they have using the drug at home. During clinic visits, participants will have physical exams with blood and urine tests. They will complete questionnaires about their health, sleep habits, and fatigue symptoms. During overnight visits, participants will also have 24-hour urine collection. A study team member will call participants 1 week after the first dose to check on their health. Follow-up phone calls will then be every 2 weeks after each clinic visit. Participants may meet with a dietitian to discuss nutrition while taking the ManNAc. Participants may choose to have genetic tests.
Study Details
Timeline
Arms & Interventions
Interventions
2 grams twice daily by mouth