SARO.19.004

10 evidence topics · 1 source

Objective

Renal-impairment pharmacokinetic objective

“severe RI” (opens the source at this quote in a new tab)

Location and study date

No evidence found.

Study design

Single-dose design

“single-dose PK” (opens the source at this quote in a new tab)

Eligibility criteria

Severe renal-impairment population

“severe renal impairment” (opens the source at this quote in a new tab)

Treatment

Single oral dose

Treatment	Dose
Saroglitazar, mg	“2”

Study outcomes

Rationale for using pharmacokinetic parameters as the primary endpoint

Not applicable.

Statistical analysis description

Number of participants (Planned and analyzed)

Renal-impairment cohort and controls

Population	Participants
Severe renal impairment	“eight”
Normal renal function controls	“eight”

Description of analysis sets

Pharmacokinetic analysis

“non-compartmental” (opens the source at this quote in a new tab)

Results

Participant disposition

No evidence found.

Baseline characteristics

Baseline sex distribution

Sex	Participants
Male	“eight”
Female	“eight”

Efficacy results

Single-dose exposure relative to controls

“comparable to matched controls” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

Single-dose safety assessment

“without significant safety issues” (opens the source at this quote in a new tab)

Study limitations

Summary

This single-dose comparison included eight participants with severe renal impairment and eight controls. It does not establish repeated-dose safety, PBC efficacy, or dosing in participants with combined hepatic and renal impairment.