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An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Nov 30, 2027 → Nov 11, 2030
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from National Human Genome Research Institute (NHGRI)

Record History

The 50 most recent of 441 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Minor Start date: Oct 13, 2026 to Oct 14, 2026
  2. Minor Start date: Oct 12, 2026 to Oct 13, 2026
  3. Minor Start date: Oct 11, 2026 to Oct 12, 2026
  4. Minor Start date: Oct 8, 2026 to Oct 11, 2026
  5. Minor Start date: Oct 7, 2026 to Oct 8, 2026
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Start date: Oct 6, 2026 to Oct 7, 2026
  2. Minor Start date: Oct 5, 2026 to Oct 6, 2026
  3. Minor Start date: Oct 4, 2026 to Oct 5, 2026
  4. Minor Start date: Sep 20, 2026 to Oct 4, 2026 Eligibility criteria expanded, about 34 words · Study description expanded, about 8 words Show 2 more changesShow less
    • Eligibility criteria expanded, about 34 words
    • Study description expanded, about 8 words
  5. Minor Start date: Sep 17, 2026 to Sep 20, 2026v432
  1. Notable Primary completion pushed from Nov 30, 2027 to Nov 11, 2030 Completion pushed from Dec 1, 2027 to Dec 1, 2030 · Start date: Sep 16, 2026 to Sep 17, 2026v431 Show 2 more changesShow less
    • Completion pushed from Dec 1, 2027 to Dec 1, 2030
    • Start date: Sep 16, 2026 to Sep 17, 2026
  2. Minor Start date: Sep 15, 2026 to Sep 16, 2026v430
  3. Notable Primary completion date: Nov 30, 2027 to Nov 11, 2030 Completion date: Dec 1, 2027 to Dec 1, 2030 · Start date: Sep 14, 2026 to Sep 15, 2026v429 Show 2 more changesShow less
    • Completion date: Dec 1, 2027 to Dec 1, 2030
    • Start date: Sep 14, 2026 to Sep 15, 2026
  4. Minor Start date: Sep 10, 2026 to Sep 14, 2026v428
  5. Minor Start date: Sep 9, 2026 to Sep 10, 2026v427
  6. Minor Start date: Sep 8, 2026 to Sep 9, 2026v426
  7. Minor Start date: Sep 7, 2026 to Sep 8, 2026v425
  8. Minor Start date: Sep 6, 2026 to Sep 7, 2026v424
  9. Minor Start date: Sep 3, 2026 to Sep 6, 2026v423
  10. Minor Start date: Sep 2, 2026 to Sep 3, 2026v422
  11. Minor Start date: Sep 1, 2026 to Sep 2, 2026v421
  12. Notable Primary endpoint(s) modified Start date: Aug 31, 2026 to Sep 1, 2026v420 Show 1 more changeShow less
    • Start date: Aug 31, 2026 to Sep 1, 2026

    See this version in full on ClinicalTrials.gov ↗

  13. Minor Start date: Aug 30, 2026 to Aug 31, 2026v419
  14. Minor Start date: Aug 27, 2026 to Aug 30, 2026v418
  15. Minor Start date: Aug 26, 2026 to Aug 27, 2026v417
  16. Minor Start date: Aug 25, 2026 to Aug 26, 2026v416
  17. Minor Start date: Aug 24, 2026 to Aug 25, 2026v415
  18. Minor Start date: Aug 23, 2026 to Aug 24, 2026v414
  19. Minor Start date: Aug 20, 2026 to Aug 23, 2026v413
  20. Minor Start date: Aug 19, 2026 to Aug 20, 2026v412
  21. Minor Start date: Aug 18, 2026 to Aug 19, 2026v411
  22. Minor Start date: Aug 17, 2026 to Aug 18, 2026v410
  23. Minor Start date: Aug 16, 2026 to Aug 17, 2026v409
  24. Minor Start date: Aug 13, 2026 to Aug 16, 2026v408
  25. Minor Start date: Aug 12, 2026 to Aug 13, 2026v407
  26. Minor Start date: Aug 11, 2026 to Aug 12, 2026v406
  27. Minor Start date: Aug 10, 2026 to Aug 11, 2026v405
  28. Minor Start date: Aug 7, 2026 to Aug 10, 2026v404
  29. Minor Start date: Aug 6, 2026 to Aug 7, 2026v403
  30. Minor Start date: Aug 5, 2026 to Aug 6, 2026v402
  31. Minor Start date: Aug 4, 2026 to Aug 5, 2026v401
  32. Minor Start date: Aug 3, 2026 to Aug 4, 2026v400
  33. Minor Start date: Aug 2, 2026 to Aug 3, 2026v399
  34. Minor Start date: Jul 30, 2026 to Aug 2, 2026v398
  35. Minor Start date: Jul 29, 2026 to Jul 30, 2026v397
  36. Minor Start date: Jul 28, 2026 to Jul 29, 2026v396
  37. Minor Start date: Jul 27, 2026 to Jul 28, 2026v395
  38. Minor Start date: Jul 26, 2026 to Jul 27, 2026v394
  39. Minor Start date: Jul 23, 2026 to Jul 26, 2026v393
  40. Minor Start date: Jul 22, 2026 to Jul 23, 2026v392
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 (FSGS), Minimal Change Disease (MCD), or Membranous Nephropathy (MN). 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.
Trial Details
NCT Number NCT06664814
Lead Sponsor National Human Genome Research Institute (NHGRI)
Conditions Focal Segmental Glomerulosclerosis, Minimal Change Disease, Membranous Nephropathy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov