Actively Recruiting
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
Led by Kind Pharmaceuticals LLC · Updated on 2026-03-27
300
Participants Needed
1
Research Sites
78 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 anemic patients with End-Stage-Kidney-Disease (ESKD)
CONDITIONS
Official Title
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving stable hemodialysis or peritoneal dialysis for end-stage kidney disease for at least 16 weeks
- Compliance with prescribed dialysis treatment
- On intravenous or subcutaneous ESA treatment for at least 6 weeks
- Average hemoglobin level between 9.0 and 12.0 g/dL during screening
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal
- Transferrin saturation 20% or higher or ferritin 100 ng/mL or higher at screening
- Serum folate and vitamin B12 at or above the lower limit of normal at screening
You will not qualify if you...
- Retinal neovascular lesions needing treatment
- Chronic inflammatory or autoimmune diseases affecting erythropoiesis
- History of gastric or intestinal surgery affecting drug absorption or active gastroparesis
- Uncontrolled hypertension with systolic >180 mmHg or diastolic >110 mmHg
- Congestive heart failure classified as New York Heart Association Class III or higher
- Recent history (within 24 weeks) of stroke, transient ischemic attack, heart attack, thromboembolic events, or lung infarction
- Significant or active liver disease
- History of seizures or seizure disorder
- Serum albumin less than 2.5 g/dL at screening
- Prior liver-related adverse effects from ESA or HIF-PHI treatment
- 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
Fudan Univeristy Zhongshan Hospital
Shanghai, China, 200032
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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