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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis

NCT07916181

This study is recruiting at 2 US sites in 1 state, according to its ClinicalTrials.gov record last updated .

Summary

This study will evaluate how fosmanogepix is processed by the body (pharmacokinetics, PK) in participants with kidney failure (end-stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) compared with participants with normal kidney function (control group). Fosmanogepix is given by intravenous infusion and is converted in the body to manogepix, the active form of the drug. Fosmanogepix is an investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory authority for use in humans.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • End Stage Renal Disease on Dialysis
  • Adult

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1
Ages
18 to 80 years
Sex
All
Healthy volunteers
Accepted
Sponsor
Basilea Pharmaceutica
Last updated on ClinicalTrials.gov
November 4, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 2

  • Orlando Clinical Research Center · Orlando, FL
  • Genesis Clinical Research · Tampa, FL

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.