NCT07487727 A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 240 participants in total. It began in 2025-12-03 with a primary completion date of 2026-12-01.

Brief Summary

This is a Phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment

Eligibility Criteria

Key Inclusion Criteria: * A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula. * Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment. * Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment 1. ESA/HIF-PHI-naïve: Defined as no use of any ESA/HIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g/dL and \<10.0 g/dL with a difference of ≤1.3 g/dL between the two values; 2. ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g/dL inclusive. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3× upper limit of normal (ULN) * Transferrin saturation (TSAT) ≥20% or ferritin ≥100 ng/mL at screening test * Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test Key Exclusion Criteria: * Concurrent retinal neovascular lesions requiring treatment. * Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms. * History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment. * Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \>180 mmHg, or diastolic blood pressure \>110 mmHg during the screening assessment * Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher). * History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment. * Participants with a history of significant liver disease or active liver disease. * History of a seizure disorder or any occurrence of seizures in the past. * Serum albumin (ALB) \< 2.5 g/dL at screening test. * Prior ESA/HIF-PHI treatment caused total bilirubin \>1.5xULN, or AST/ALT/ALP\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.). * Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.

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