Oral Enarodustat for Treating Anemia in Adults with Non-Dialysis Chronic Kidney Disease Evaluating Safety and Dosing by Inflammation Levels

What this Trial Is About

Researchers are studying the effects of oral enarodustat on adults with anemia related to non-dialysis chronic kidney disease ND-CKD. This real-world observational study aims to assess the drugs safety and effectiveness, particularly how different levels of inflammation influence treatment response. Ninety participants are divided into three groups based on their baseline C-reactive protein CRP levels to better understand individualized dosing needs in this population. Participants receive oral enarodustat starting at 4 mg once daily, with doses adjusted between 1 mg and 8 mg every 4 weeks to maintain hemoglobin levels between 110-130 gL. Iron supplements may be given if iron deficiency is detected, and standard kidney disease treatments continue as usual. The study involves a 24-week follow-up period with visits every 4 weeks for dose adjustments and monitoring. During the study, participants undergo blood tests every 4 weeks to track hemoglobin, iron metabolism, inflammation, and other health markers. Extended biomarker assessments occur at the start, week 12, and week 24. Researchers record medication use, vital signs, and any adverse events throughout. The main goal is to compare hemoglobin changes at 24 weeks across inflammation groups while also examining iron and inflammatory markers and documenting any side effects.

Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients