Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07494409 for Anemia Due to Chronic Kidney Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia Phase 3 300 Randomized Open-Label
Clinical Trial NCT07494409 is designed to study Treatment for Anemia Due to Chronic Kidney Disease. It is a Phase 3 interventional study that is recruiting, having started on 31 October 2025, with plans to enroll 300 participants. Led by Kind Pharmaceuticals LLC, it is expected to complete by 30 April 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief 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)
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
Conditions
Anemia Due to Chronic Kidney DiseaseOther Study IDs
- AND017-CN-302
- CTR20253615 (Other Identifier) (China National Medical Products Administration)
NCT ID Number
Start Date (Actual)
2025-10-31
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-04-30
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
anemia
CKD
ESKD
CKD
ESKD
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAND017 | AND017 capsules AND017 capsules administered orally with a starting dose of 10 mg TIW |
Active ComparatorErythropoiesis Stimulating Agents (ESA) | ESA ESA injection and dose based on package insert and local practice |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | From Week 23 to Week 27 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From baseline to Week 53 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Kind Pharmaceuticals LLCStudy Central Contact
Contact: Yusha Zhu, MD, PhD, 6467252552, [email protected]
1 Study Locations in 1 Countries
Fudan Univeristy Zhongshan Hospital, Shanghai, 200032, China
Xiaoqiang Ding, Principal Investigator
Recruiting