💬In plain words
What the trial is, and whether it could suit you
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)
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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