End Stage Renal Disease on DialysisPhase 1NCT07916181
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
A Phase 1 study testing Intravenous fosmanogepix in people with End Stage Renal Disease on Dialysis and Adult, run by Basilea Pharmaceutica at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Adult
- What is being tested?
- Intravenous fosmanogepix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2026to 1 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
- Recruiting
Genesis Clinical Research
Tampa, Florida, 33603
About this study
Official title: A Phase 1, Non-randomized, Open-label, Multi-center Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Fosmanogepix in Adult Subjects With End-stage Renal Disease Requiring Intermittent Hemodialysis
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.
Read more
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.
- Conditions
- End Stage Renal Disease on Dialysis, Adult
- Being tested
- Intravenous fosmanogepix
- Keywords
- Pharmacokinetics, Fosmanogepix, Manogepix, Adults, ESRD requiring IHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous fosmanogepixDrug
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2.
Intravenous fosmanogepixDrug
Two doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2)
| Study group | Role | What they receive |
|---|---|---|
| Period 1 and Period 2 | Experimental | Participants with end stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) Receives: Drug: Intravenous fosmanogepix |
| Period 1 | Experimental | Participants with normal renal function (control group) Receives: Drug: Intravenous fosmanogepix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of manogepix
Cmax of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Measured: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Area under the concentration-time curve (AUC) of manogepix
AUC of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Measured: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 will be assessed after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Measured: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Tmax of manogepix (total and unbound) Periods 1 and 2
Impact of IHD on the Tmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Measured: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Cmax of manogepix (total and unbound) Periods 1 and 2
Impact of IHD on the Cmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in participants with ESRD requiring IHD.
Measured: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Secondary outcomes (1)
Number of participants reporting treatment emergent adverse events (TEAEs)
To evaluate the safety and tolerability of fosmanogepix in participants with ESRD requiring IHD, and in healthy participants.
Measured: From screening to up to 35 days after last study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start27 Oct 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Kaindl, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916181
- Sponsor's protocol ID
- FMGX-CP-111
- Other IDs
- 75A50124C00033
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Non-randomized, Open-label, Multi-center Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Fosmanogepix in Adult Subjects With End-stage Renal Disease Requiring Intermittent Hemodialysis
- ClinicalTrials.gov ID
- NCT07916181
- Acronym / sponsor ID
- FMGX-CP-111
- Conditions
- End Stage Renal Disease on Dialysis, Adult
- Keywords
- Pharmacokinetics, Fosmanogepix, Manogepix, Adults, ESRD requiring IHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 and Period 2 | Experimental | Drug: Intravenous fosmanogepixParticipants with end stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) |
| Period 1 | Experimental | Drug: Intravenous fosmanogepixParticipants with normal renal function (control group) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous fosmanogepixTwo doses of intravenous fosmanogepix will be administered on Day 1 and Day 2. | Drug | Period 1 |
| Intravenous fosmanogepixTwo doses of intravenous fosmanogepix will be administered on Day 1 and Day 2 in each period (Period 1 and 2) | Drug | Period 1 and Period 2 |
Primary outcome
Maximum Plasma Concentration (Cmax) of manogepix
Time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Cmax of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Area under the concentration-time curve (AUC) of manogepix
Time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
AUC of manogepix will be assessed in participants with ESRD in Period 2 and compared with that of healthy participants in Period 1.
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2
Time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 will be assessed after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Impact of IHD on the Tmax of manogepix (total and unbound) Periods 1 and 2
Time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Tmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in subjects with ESRD requiring IHD.
Impact of IHD on the Cmax of manogepix (total and unbound) Periods 1 and 2
Time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.
Impact of IHD on the Cmax of manogepix (total and unbound) will be assessed in Periods 1 and 2 after fosmanogepix IV administration in participants with ESRD requiring IHD.
1 secondary outcome
Number of participants reporting treatment emergent adverse events (TEAEs)
Time frame: From screening to up to 35 days after last study drug administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Kaindl, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous fosmanogepix in people with End Stage Renal Disease on Dialysis and Adult, run by Basilea Pharmaceutica at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Kaindl, MD (+41615671505, thomas.kaindl@basilea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of manogepix (time frame: Blood sampling in Period 1: At Day 1, 2, 3, 4, 5 and 6. Blood sampling in Period 2: At Day 1, 2, 3, 4, 5, 6, 8, 11, 13 and 15.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.