A study to Assess the Effect of Vonafexor on Kidney Function in Subjects With Impaired Renal Function and Suspected MASH

Conditions

Impaired renal function and suspected MASH

Brief summary

Change from baseline of mGFRiohexol and eGFRcreat at W16

Detailed description

Plasma concentrations pre-dose (0h) and post-dose (2h, 5h, and 7h) on Day 1 (W0) and D113 (W16), which will be modelled against the MASH PopPK expected values., Change from baseline mGFRiohexol off treatment at W24., Change from baseline of eGFRcreat on treatment at W4, W8, W12 and off treatment at W20, W24 and W28, Correlation of mGFRiohexol with eGFRcreat at baseline, on treatment at W16 and off treatment at W24, Levels and change in albuminuria (Urinary Albumin to Creatinine Ratio (UACR) and proteinuria (Urinary Protein to Creatinine ratio (UPCR)) in morning urine samples at baseline, on treatment at W4, W8, W12, W16 with off treatment at W20, W24 and W28., AEs, SAEs, Changes from baseline at W16 in laboratory safety parameters, physical examination, vital signs and ECGs

Related papers

No related papers found yet.

Interventions

DRUGVonafexor

DRUGROSUVASTATIN

DRUGIOHEXOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline of mGFRiohexol and eGFRcreat at W16	—

Secondary

Measure	Time frame
Plasma concentrations pre-dose (0h) and post-dose (2h, 5h, and 7h) on Day 1 (W0) and D113 (W16), which will be modelled against the MASH PopPK expected values., Change from baseline mGFRiohexol off treatment at W24., Change from baseline of eGFRcreat on treatment at W4, W8, W12 and off treatment at W20, W24 and W28, Correlation of mGFRiohexol with eGFRcreat at baseline, on treatment at W16 and off treatment at W24, Levels and change in albuminuria (Urinary Albumin to Creatinine Ratio (UACR) and proteinuria (Urinary Protein to Creatinine ratio (UPCR)) in morning urine samples at baseline, on treatment at W4, W8, W12, W16 with off treatment at W20, W24 and W28., AEs, SAEs, Changes from baseline at W16 in laboratory safety parameters, physical examination, vital signs and ECGs	—

Measure

Time frame

Plasma concentrations pre-dose (0h) and post-dose (2h, 5h, and 7h) on Day 1 (W0) and D113 (W16), which will be modelled against the MASH PopPK expected values., Change from baseline mGFRiohexol off treatment at W24., Change from baseline of eGFRcreat on treatment at W4, W8, W12 and off treatment at W20, W24 and W28, Correlation of mGFRiohexol with eGFRcreat at baseline, on treatment at W16 and off treatment at W24, Levels and change in albuminuria (Urinary Albumin to Creatinine Ratio (UACR) and proteinuria (Urinary Protein to Creatinine ratio (UPCR)) in morning urine samples at baseline, on treatment at W4, W8, W12, W16 with off treatment at W20, W24 and W28., AEs, SAEs, Changes from baseline at W16 in laboratory safety parameters, physical examination, vital signs and ECGs

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Countries

Germany

Outcome results

None listed