Anemia Due to Chronic Kidney DiseasePhase 3NCT07494409
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
A Phase 3 study testing AND017 capsules and ESA in people with Anemia Due to Chronic Kidney Disease, run by Kind Pharmaceuticals LLC at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia Due to Chronic Kidney Disease
- What is being tested?
- AND017 capsules and ESA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2025to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Univeristy Zhongshan Hospital
Shanghai, 200032
Xiaoqiang Ding
About this study
Official title: 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)
- Conditions
- Anemia Due to Chronic Kidney Disease
- Being tested
- AND017 capsules, ESA
- Keywords
- anemia, CKD, ESKD
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AND017 capsulesDrug
AND017 capsules administered orally with a starting dose of 10 mg TIW
ESADrug
ESA injection and dose based on package insert and local practice
| Study group | Role | What they receive |
|---|---|---|
| AND017 | Experimental | Not described Receives: Drug: AND017 capsules |
| Erythropoiesis Stimulating Agents (ESA) | Active comparator | Not described Receives: Drug: ESA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD
The mean Hb levels averaged over Week 23-27
Measured: From Week 23 to Week 27
Secondary outcomes (15)
The percentage of responders
Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27
Measured: From baseline to Week 27
Percentage of participants that maintained Hb level over target lower limit
Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27
Measured: From Week 5 to Week 27
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period.
During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive)
Measured: From baseline to Week 53
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period
During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or < 7.5 g/dL
Measured: From baseline to Week 53
Incidence of excessive erythropoiesis
During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g/dL within any 2-week period and an Hb increase ≥ 2.0 g/dL within any 4-week period respectively
Measured: From baseline to Week 53
The cumulative incidence of Hb non-response
The cumulative incidence of Hb non-response is defined as Hb < 10.0 g/dL and an increase from baseline < 1.0 g/dL averaged over Weeks 5-27
Measured: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 5-27
Mean Hb change from baseline averaged over Weeks 5-27
Measured: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 23-27
Mean Hb change from baseline averaged over Weeks 23-27
Measured: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 13-17
Mean Hb change from baseline averaged over Weeks 13-17
Measured: From baseline to Week 17
Mean Hb change from baseline averaged over Weeks 27-53
Mean Hb change from baseline averaged over Weeks 27-53
Measured: From baseline to Week 53
Mean Hb change from baseline averaged over Weeks 49-53
Mean Hb change from baseline averaged over Weeks 49-53
Measured: Mean Hb change from baseline averaged over Weeks 49-53
During the entire treatment period, mean Hb at each visit
During the entire treatment period, mean Hb at each visit
Measured: From baseline to Week 53
The use of intravenous iron during the entire study treatment period
The percentage of participants that have received intravenous iron during the entire study treatment period
Measured: From baseline to Week 53
The mean weekly dose of intravenous iron during the entire treatment period
The mean weekly dose of intravenous iron during the entire treatment period
Measured: From baseline to Week 53
The time to first initiation of intravenous iron during the entire treatment period
The time to first initiation of intravenous iron during the entire treatment period
Measured: From baseline to Week 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start31 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia Due to Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kind Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusha Zhu, MD, PhD, Study director, Kind Pharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494409
- Sponsor's protocol ID
- AND017-CN-302
- Other IDs
- CTR20253615
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07494409
- Acronym / sponsor ID
- AND017-CN-302
- Conditions
- Anemia Due to Chronic Kidney Disease
- Keywords
- anemia, CKD, ESKD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kind Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AND017 | Experimental | Drug: AND017 capsules |
| Erythropoiesis Stimulating Agents (ESA) | Active comparator | Drug: ESA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AND017 capsulesAND017 capsules administered orally with a starting dose of 10 mg TIW | Drug | AND017 |
| ESAESA injection and dose based on package insert and local practice | Drug | Erythropoiesis Stimulating Agents (ESA) |
Primary outcome
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD
Time frame: From Week 23 to Week 27
The mean Hb levels averaged over Week 23-27
15 secondary outcomes
The percentage of responders
Time frame: From baseline to Week 27
Percentage of participants that maintained Hb level over target lower limit
Time frame: From Week 5 to Week 27
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period.
Time frame: From baseline to Week 53
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period
Time frame: From baseline to Week 53
Incidence of excessive erythropoiesis
Time frame: From baseline to Week 53
The cumulative incidence of Hb non-response
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 5-27
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 23-27
Time frame: From baseline to Week 27
Mean Hb change from baseline averaged over Weeks 13-17
Time frame: From baseline to Week 17
Mean Hb change from baseline averaged over Weeks 27-53
Time frame: From baseline to Week 53
Mean Hb change from baseline averaged over Weeks 49-53
Time frame: Mean Hb change from baseline averaged over Weeks 49-53
During the entire treatment period, mean Hb at each visit
Time frame: From baseline to Week 53
The use of intravenous iron during the entire study treatment period
Time frame: From baseline to Week 53
The mean weekly dose of intravenous iron during the entire treatment period
Time frame: From baseline to Week 53
The time to first initiation of intravenous iron during the entire treatment period
Time frame: From baseline to Week 53
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusha Zhu, MD, PhD study director
Kind Pharmaceuticals LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AND017 capsules and ESA in people with Anemia Due to Chronic Kidney Disease, run by Kind Pharmaceuticals LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusha Zhu, MD, PhD (6467252552, yushazhu@kindpharmaceutical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD (time frame: From Week 23 to Week 27). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.