AND017 capsules for anemia in people with chronic kidney disease on dialysis
Tests AND017 against an existing medicine for anemia in adults on dialysis.
Plain-language title generated from the registry record
Registry title: A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07494409, who can take part
Where in China
- Fudan Univeristy Zhongshan HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kind Pharmaceuticals LLC
- Trial code
- NCT07494409
- Record updated
- 27 March 2026
- Original description
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)Read full original descriptionShow less
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
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)
Inclusion: 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.
Exclusion: 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; 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; Any prior functioning organ transplant or a scheduled organ transplantation, or anephric; 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; 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.).