A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (D… (NCT07494409) | Clinical Trial Compass
RecruitingPhase 3
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
China300 participantsStarted 2025-10-31
Plain-language 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD