Abstract: INFO20-TH
Phase 3 Study of AND017, a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI), in Patients with Anemia Due to Nondialysis-Dependent CKD (NDD-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
- Zuo, Li, Peking University People's Hospital, Beijing, Beijing, 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 associated with chronic kidney disease (CKD). A Phase 2 clinical trial was completed in the United States and China in patients with non–dialysis-dependent (NDD) CKD. The results demonstrated that AND017 effectively increased and maintained hemoglobin (Hb) levels within the target range over the 13 weeks of treatment, with a significantly greater rate of Hb rise compared to placebo. AND017 also showed favorable safety profile with no special safety signals identified in the study. 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 patients with NDD-CKD.
A Phase 3 study of AND017 is planned in anemic patients with NDD-CKD. This multicenter, randomized, open-label, active-controlled trial will evaluate the efficacy and safety of AND017 compared with the active control erythropoiesis-stimulating agent (ESA). Approximately 240 patients will be enrolled and randomized in a 2:1 ratio to receive either AND017 or ESA treatment. The initial treatment period will last 26 weeks, followed by a 26-week extension period for all patients of AND017 arm for longer-term follow-up. Both ESA-naïve and ESA-treated patients will be eligible for enrollment, with screening Hb levels of 7.5–10.0 g/dL and 9.0–12.0 g/dL, respectively. The starting dose of AND017 will be 8 mg three times per week (TIW) for ESA-naïve patients and 10 mg TIW for ESA-treated patients. Once a patient’s Hb level reaches a desirable range as designated in the protocol, the dosing frequency of AND017 will be switched to once weekly (QW). Dose adjustments of AND017 will be made in 4 mg increments, either TIW or QW, primarily 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 treatment 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.