Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.

  • STATUS
    Recruiting
  • participants needed
    16
  • sponsor
    VectivBio AG
Updated on 1 August 2021

Summary

Study of pharmacokinetics and safety of apraglutide in participants with normal and impaired kidney function.

Description

A two stage design, open label, multi-center, non-randomized trial to evaluate the PK and safety of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of renal function. The renal function will be calculated by the estimated glomerular filtration rate (eGFR) according to the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation.

Part 1: 8 subjects with severe renal impairment (Cohort 1) and 8 subjects with normal renal function (Cohort 2).

Part 2: 8 subjects with moderate (Cohort 3) and 8 subjects with mild (Cohort 4). Part 2 will be conducted if the geometric mean ratio (GMR) of AUC-inf or AUC_last for the severe renal impairment group compared to the control group is 2.

Details
Condition chronic renal insufficiency, Chronic renal failure, chronic kidney disease, chronic kidney disease (ckd)
Treatment apraglutide
Clinical Study IdentifierNCT04699032
SponsorVectivBio AG
Last Modified on1 August 2021

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