NCT07916181 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
| NCT ID | NCT07916181 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Basilea Pharmaceutica |
| Condition | End Stage Renal Disease on Dialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10-27 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-10-27 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. The study will also evaluate the effect of hemodialysis on manogepix levels in participants with ESRD. The safety and tolerability of fosmanogepix will also be assessed in participants with kidney failure and in matched participants with normal kidney function. Participation in the study will last up to 11 weeks and will include up to two study periods. Participants with ESDR requiring IHD will receive fosmanogepix in two study periods. Healthy participants will receive fosmanogepix in one study period. The study will be conducted at two study sites in the United States.
Eligibility Criteria
Inclusion Criteria: * Body mass index of 18 to 42 kg/m2, inclusive, and a total body weight \> 50 kg at Screening. * Subjects with normal renal function only: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min * Subjects with ESRD requiring IHD only: Hemodialysis treatment for at least 3 months prior to Screening, with dialysis performed ≥ 3 times per week and adequate dialysis efficiency as established by document Kt/V ≥ 1.2 on current regimen. The clinical status of the underlying ESRD should be stable Exclusion Criteria: * Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study. * Laboratory abnormality or other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, that may increase the risk to study participation, or in the Investigator's judgment, make the subject inappropriate for the study. * History or presence of clinically-significant disorders, which, in the opinion of the Investigator, are capable of significantly altering the distribution, metabolism, or elimination of the study drug. * Renal or liver transplant recipients * Hepatic impairment not related to ESRD * Use of any prohibited medication within five half-lives plus 14 days prior to Day -1 Subjects with ESRD requiring IHD only: -Not on stable dosing regimen (i.e., \< 3 weeks prior to Screening) of prescription/ non prescription drugs (including dietary/herbal supplements) for the treatment of a stable concomitant disease
Contact & Investigator
Thomas Kaindl, MD
STUDY DIRECTOR
Basilea Pharmaceutica International Ltd, Allschwil
Frequently Asked Questions
Who can join the NCT07916181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying End Stage Renal Disease on Dialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07916181 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07916181 currently recruiting?
Yes, NCT07916181 is actively recruiting participants. Contact the research team at thomas.kaindl@basilea.com for enrollment information.
Where is the NCT07916181 trial being conducted?
This trial is being conducted at Orlando, United States, Tampa, United States.
Who is sponsoring the NCT07916181 clinical trial?
NCT07916181 is sponsored by Basilea Pharmaceutica. The principal investigator is Thomas Kaindl, MD at Basilea Pharmaceutica International Ltd, Allschwil. The trial plans to enroll 20 participants.