Pharmacokinetics, Elimination and Dialyzability of HRS-9231 in Patients with Varying Degrees of Renal Impairment.
Qiwen Han, Rongjun Zhang, Yan He et al.
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In 30 seconds
This Phase I clinical trial evaluated the pharmacokinetics, elimination, and dialyzability of HRS-9231 in 40 patients with varying degrees of renal impairment, including those on hemodialysis. Results showed that systemic exposure increased with renal impairment severity, with a 333% higher AUC in severe impairment compared to normal function. Hemodialysis effectively removed HRS-9231, achieving an 84% reduction in plasma concentration after the first session.
Key findings
- AUC 0-∞ increased by 333% in severe renal impairment compared to normal function.
- Mean terminal half-life prolonged from 1.7 h in normal function to 7.2 h in severe impairment.
- Hemodialysis reduced plasma concentration of HRS-9231 by 84% after the first session.
- No cases of nephrogenic systemic fibrosis were observed during the 6-month follow-up.
Why it matters
Understanding the pharmacokinetics and safety profile of HRS-9231 in patients with renal impairment is crucial for clinicians to ensure safe use of gadolinium-based contrast agents, particularly in vulnerable populations requiring hemodialysis.