Actively Recruiting
A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
Led by Kind Pharmaceuticals LLC · Updated on 2026-03-27
240
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with chronic kidney disease (CKD) stage 3, 4, or 5 confirmed by estimated Glomerular Filtration Rate (eGFR)
- Not on dialysis and no expected need for dialysis during the study
- ESA/HIF-PHI-naive patients: no ESA or HIF-PHI treatment for at least 12 weeks before randomization with hemoglobin between 7.5 and less than 10.0 g/dL and minimal variation between two recent values
- ESA-treated patients: received ESA treatment for at least 6 weeks before randomization with stable hemoglobin between 9.0 and 12.0 g/dL
- Liver enzymes (AST and ALT) less than three times the upper limit of normal
- Transferrin saturation (TSAT) of 20% or higher or ferritin of at least 100 ng/mL
- Serum folate and vitamin B12 levels at or above the lower limit of normal
You will not qualify if you...
- Retinal neovascular lesions requiring treatment
- Chronic inflammatory diseases besides glomerulonephritis or autoimmune diseases with inflammatory symptoms
- History of gastric or intestinal surgery affecting drug absorption or symptomatic gastroparesis despite treatment
- Uncontrolled hypertension with systolic blood pressure over 180 mmHg or diastolic over 110 mmHg
- Congestive heart failure classified as New York Heart Association (NYHA) Class III or higher
- History of stroke, transient ischemic attack, heart attack, blood clots, or lung infarction within 24 weeks before screening
- Significant or active liver disease
- History of seizures or seizure disorder
- Serum albumin less than 2.5 g/dL
- Prior ESA or HIF-PHI treatment causing serious liver enzyme elevations or serious liver disease
- Previous or planned organ transplant or absence of kidneys
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yusha Zhu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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