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, Phase 1, Recruiting, Basilea Pharmaceutica
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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 | ClinicalTrials.gov |
| NCT number | NCT07916181 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Basilea Pharmaceutica | ClinicalTrials.gov |
| Conditions | End Stage Renal Disease on Dialysis, Adult | ClinicalTrials.gov |
| Interventions | Intravenous fosmanogepix, Intravenous fosmanogepix | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of manogepix | 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. | ClinicalTrials.gov |
| Primary | Area under the concentration-time curve (AUC) of manogepix | 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. | ClinicalTrials.gov |
| Primary | Impact of IHD on the AUC of manogepix (total and unbound) in Periods 1 and 2 | 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. | ClinicalTrials.gov |
| Primary | Impact of IHD on the Tmax of manogepix (total and unbound) Periods 1 and 2 | 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. | ClinicalTrials.gov |
| Primary | Impact of IHD on the Cmax of manogepix (total and unbound) Periods 1 and 2 | 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. | ClinicalTrials.gov |
| Secondary | Number of participants reporting treatment emergent adverse events (TEAEs) | From screening to up to 35 days after last study drug administration. | To evaluate the safety and tolerability of fosmanogepix in participants with ESRD requiring IHD, and in healthy participants. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)