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A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants with Normal Renal Function

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04699877

Astellas Study ID

The unique identification code given by the study sponsor.

2215-CL-0114

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2020-003993-32

Follow Trial

Condition

Kidney Disease, Other

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - 75 Years

Sex

Female & Male

Product

gilteritinib

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jan 2021 - Jul 2022

Masking

None (Open Label)

Enrollment number

17

A Phase 1 Open-label Study to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Gilteritinib Compared to Healthy Participants with Normal Renal Function

Study summary

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Locations

Orlando Clinical Research Center

Orlando, United States, 32809

National Institute of Clinical Research

Garden Grove, United States, 92844

Orange County Research Institute

Tustin, United States, 92780

Site BG35901

Sofia, Bulgaria, 1000

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