New pill could replace needles for anemia in dialysis patients
NCT ID NCT07494409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests an oral drug called AND017 for anemia in people on dialysis due to end-stage kidney disease. About 300 participants will receive either AND017 capsules or a standard injected ESA. The goal is to see if AND017 can maintain healthy hemoglobin levels as well as or better than current treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AND017 capsules
- What this could lead to
- If successful, AND017 could offer a new oral option to manage anemia in dialysis patients, potentially reducing the need for injections.
- What could go wrong
- This is still an early Phase 3 trial with 300 participants. The drug may not prove better than existing treatments, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan Univeristy Zhongshan Hospital
RECRUITINGShanghai, 200032, China
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