Abstract: INFO14-TH
A Phase 3 Study of AND017, a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, in Patients with Anemia Due to Nondialysis-Dependent CKD (NDD-CKD) in the United States
Session Information
- Informational Posters - 1
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- No subcategory defined
Authors
- Zhu, Yusha, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Wilson, Suzanne, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Li, Xiaolu, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Zhu, Qi, Kind Pharmaceuticals LLC, Redwood City, California, United States
- Block, Geoffrey A., US Renal Care Inc, Decatur, Georgia, United States
- Pergola, Pablo E., Renal Associates Northeast San Antonio, San Antonio, Texas, United States
Description
AND017 is a novel hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) for the treatment of anemia associated with chronic kidney disease (CKD). In two Phase II studies conducted in the United States and China involving erythropoiesis-stimulating agent (ESA)-naïve patients with non–dialysis-dependent CKD (NDD-CKD) and ESA-treated patients with dialysis-dependent CKD (DD-CKD), AND017, administered using either three-times-weekly (TIW) or once-weekly (QW) dosing regimens, increased and maintained hemoglobin (Hb) levels within the target range and demonstrated a favorable safety profile. These results support the continued development of AND017 for the treatment of anemia in CKD. Two Phase III studies are currently ongoing in China, with efficacy and safety findings consistent with those observed in the Phase II studies conducted in the US.
A planned Phase III study will be conducted in the United States, following discussions with the FDA to ensure alignment with current international guidance and regulatory requirements. This is a 52-week, multicenter, randomized, open-label, active-controlled trial to evaluate the efficacy and safety of AND017 compared with ESA therapy.
Approximately 240 patients with NDD-CKD, including both ESA-naïve and ESA-treated patients, will be enrolled and randomized in a 2:1 ratio to receive either AND017 or ESA treatment. Eligible patients must have screening Hb levels of 7.5–10.0 g/dL if ESA-naïve and 9.0–11.0 g/dL if ESA-treated. The Initial Treatment Period will last 28 weeks, followed by a 24-week Extended Treatment Period for longer-term follow-up. The starting dose of AND017 will be 8 mg TIW for ESA-naïve patients and 10 mg TIW for ESA-treated patients. Once a patient’s Hb reaches the target range, dosing will transition to a QW regimen. Dose adjustments will be made throughout the study based on Hb measurements. The primary efficacy endpoint is the mean Hb level during Weeks 25-29. The non-inferiority of AND017 compared with ESA treatment will be established if the lower bound of the two-sided 95% CI for the Hb difference is ≥ -0.75 g/dL.