A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients
Kind Pharmaceuticals LLC
240 participants
Dec 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
- 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;
- 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
Exclusion Criteria11
- 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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Interventions
AND017 capsules administered orally with a starting dose of 8 mg TIW for ESA naive patients or 10 mg TIW for ESA treated patients
ESA injection and dose based on package insert and local practice
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07487727