Impaired Renal Function/Kidney Disease Single Dose Study

  • STATUS
    Recruiting
Updated on 26 January 2021
renal impairment
kidney diseases

Summary

Single-Dose Study to Evaluate participants with normal Renal Function and Renal Impairment

Description

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of XXXX and Metabolites in Participants with Normal Renal Function and Renal Impairment

Details
Condition Renal Failure, Kidney Failure (Pediatric), Kidney Disease, Kidney Failure
Clinical Study IdentifierTX264160
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 79 yrs?
Gender: Male or Female
Do you have any of these conditions: Kidney Disease or Renal Failure or Kidney Failure or Kidney Failure (Pediatric)?
Be aged 18 through 79 years of age
Participants have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from study center admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug
Have renal impairment classification at screening that has been unchanged during the 3 months prior to screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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