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Clinical Trials in China / NCT07494409
Recruiting Phase 3

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

NCT07494409 · tracked via the Priya Life Science China tracker
Sponsor
Kind Pharmaceuticals LLC
Phase
Phase 3
Started
2025-10-31
Last updated
2026-03-27

Condition(s) studied

Anemia Due to Chronic Kidney Disease

Investigational drug(s) / intervention(s)

AND017 capsulesESA

AND017 capsules: AND017 capsules administered orally with a starting dose of 10 mg TIW

ESA: ESA injection and dose based on package insert and local practice

Study summary

This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key Inclusion Criteria: * Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription. * Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks * The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\<3× upper limit of normal (ULN) * Transferrin saturation ≥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/hypoxia-inducible factor-prolyl hydroxylase inhibitor (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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan Univeristy Zhongshan Hospital Shanghai China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07494409 on ClinicalTrials.gov ↗ ← All trials in China