A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia

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)

Study Overview

• Status: Recruiting
• Conditions: Anemia Due to Chronic Kidney Disease
• Intervention / Treatment: Drug: ESA; Drug: AND017 capsules

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yusha Zhu, MD, PhD; Phone Number: 6467252552; Email: yushazhu@kindpharmaceutical.com

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Fudan Univeristy Zhongshan Hospital
    • Principal Investigator: Xiaoqiang Ding

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AND017	Drug: AND017 capsules; AND017 capsules administered orally with a starting dose of 10 mg TIW
Active Comparator: Erythropoiesis Stimulating Agents (ESA)	Drug: ESA; ESA injection and dose based on package insert and local practice

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 49-53	Mean Hb change from baseline averaged over Weeks 49-53	Mean Hb change from baseline averaged over Weeks 49-53

Collaborators and Investigators

• Sponsor: Kind Pharmaceuticals LLC
• Investigators: Study Director: Yusha Zhu, MD, PhD, Kind Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: anemia; CKD; ESKD
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia
• Other Study ID Numbers: AND017-CN-302; CTR20253615 (Other Identifier: China National Medical Products Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No