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NCT06664814 · ClinicalTrials.gov registry record · Phase 2

An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis

A Phase 2 study of Focal Segmental Glomerulosclerosis, sponsored by National Human Genome Research Institute (NHGRI).

Recruiting
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT06664814 is a Phase 2 study of Focal Segmental Glomerulosclerosis that is actively recruiting participants, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 30 participants, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06664814, a Phase 2 study of Focal Segmental Glomerulosclerosis, is actively recruiting participants, sponsored by National Human Genome Research Institute (NHGRI).

RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG ManNAc

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-03-26
Est. Completion 2027-12-01
Phase Phase 2

What the Registry Record Tells You About NCT06664814

The ClinicalTrials.gov registry entry for NCT06664814 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The listed sponsor is National Human Genome Research Institute (NHGRI), which has 185 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which ManNAc is the first listed.

NCT06664814 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT06664814 about?

NCT06664814 is a clinical study titled "An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis". 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 t...

What is the current status of trial NCT06664814?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2026-03-26. Estimated completion is 2027-12-01.

What conditions does trial NCT06664814 study?

This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis.

What interventions are being tested in trial NCT06664814?

The interventions under investigation include: ManNAc (DRUG).

Who is sponsoring clinical trial NCT06664814?

This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06664814 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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