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Fosmanogepix for Kidney Failure

Recruiting at 1 trial location
TK
Overseen ByThomas Kaindl, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Basilea Pharmaceutica
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TK

Thomas Kaindl, MD

Principal Investigator

Basilea Pharmaceutica International Ltd, Allschwil

Are You a Good Fit for This Trial?

This trial is for adults with severe kidney failure who are on regular dialysis, as well as healthy adults with normal kidney function. Participants must be able to receive intravenous medication and meet other health requirements set by the study team.

Inclusion Criteria

My end-stage kidney disease is stable while on dialysis.
I have been on hemodialysis at least 3 times a week for 3 months with good results.
Body mass index of 18 to 42 kg/m2, inclusive, and a total body weight > 50 kg at Screening
See 1 more

Exclusion Criteria

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
Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study
I have end-stage kidney disease and my medication doses have changed in the last 3 weeks.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Fosmanogepix

Trial Overview

The study tests how safe fosmanogepix is and how it moves through the body in people with severe kidney failure on dialysis compared to those with normal kidneys. Fosmanogepix is given by IV infusion; some participants may get more than one dose.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Period 1 and Period 2Experimental Treatment1 Intervention
Group II: Period 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Basilea Pharmaceutica

Lead Sponsor

Trials
53
Recruited
9,900+

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