Abstract: INFO19-TH
Phase 3 Study of AND017, a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI), in Anemic Patients with Dialysis-Dependent CKD (DD-CKD)
Session Information
- Informational Posters - 1
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- No subcategory defined
Authors
- Zhu, Yusha, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Ding, Xiaoqiang, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
- Zhang, Xiaoyan, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
- Wilson, Suzanne, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Li, Xiaolu, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Du, Ping, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Zhu, Qi, Kind Pharmaceuticals LLC, Redwood City, California, United States
Description
AND017 is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) developed for the treatment of anemia in chronic kidney disease (CKD). A Phase 2 clinical trial conducted in the United States and China evaluated its efficacy and safety in patients with end-stage kidney disease (ESKD). The results demonstrated that AND017 effectively increased and maintained hemoglobin (Hb) levels within the target range over 20-week treatment. Both the three times weekly (TIW) and once weekly (QW) dosing regimens of AND017 were non-inferior to erythropoiesis-stimulating agent (ESA). Overall, AND017 was well tolerated with no notable safety signals identified compared to ESA. These findings provide a rationale for the dosing regimen and dose adjustment rules of AND017, supporting the continued development of AND017 in the Phase 3 study for ESKD patients.
A Phase 3 study of AND017 is planned to be conducted in patients with ESKD. This will be a multicenter, randomized, open-label, active-controlled trial designed to evaluate the efficacy and safety of AND017 compared with ESA in anemic patients with ESKD. Approximately 300 ESA-treated patients on stable dialysis will be enrolled and randomized in a 2:1 ratio to receive either AND017 or ESA. The initial treatment period will last 26 weeks, followed by a 26-week extension period for patients of AND017 arm for longer-term follow-up. Patients on stable dialysis for at least 16 weeks, treated with ESA for a minimum of 6 weeks, and with screening Hb levels ≥9.0 g/dL and ≤12.0 g/dL will be eligible for participation. The starting dose of AND017 will be 10 mg TIW. Once a patient’s Hb level reaches a desired range, the dosing frequency of AND017 will be adjusted to QW. Throughout the study, dose adjustments of AND017 will be made in 4 mg increments, either TIW or QW, mainly based on observed Hb levels throughout the study. The primary efficacy endpoint is the mean Hb level over Week 23-27 in the initial treatment period. The non-inferiority of AND017 to ESA will be established if the lower bound of the 1-sided 95% CI in mean Hb is ≥-1.0 g/dL. This protocol has been reviewed with the China NMPA and is considered a pivotal Phase 3 trial of AND017 for the treatment of anemia in CKD in China.