Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function

Summary

This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on measurement of iberdomide and M12 concentrations). Participants with severe renal impairment (RI), participants with kidney failure on intermittent hemodialysis (IHD), and participants with normal renal function are being included in the current study. Participants with severe RI and kidney failure participants will be matched to participants with normal renal function based on sex, age (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).

Timeline

Start

2021-08-12

Primary completion

2023-01-23

Completion

2023-01-23

Publications

• Chen P, Lin H, Xue Y, Thomas M, Wang A, Li Y, Cheng Y. A population pharmacokinetic analysis to evaluate the impact of renal impairment on the pharmacokinetics of iberdomide. J Pharm Sci. 2025 Feb;114(2):1315-1325. doi: 10.1016/j.xphs.2025.01.015. Epub 2025 Jan 25.

Drugs

Indications