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

NCT07494409 | Recruiting Phase 3

• 2 other identifiers: AND017-CN-302CTR20253615
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Anemia Due to Chronic Kidney Disease

Keywords

anemia; CKD; ESKD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• The percentage of responders

  From baseline to Week 27

• Percentage of participants that maintained Hb level over target lower limit

  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.

  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

  From baseline to Week 53

• Incidence of excessive erythropoiesis

  From baseline to Week 53

Study Arms (2)

AND017

EXPERIMENTAL

Drug: AND017 capsules

Erythropoiesis Stimulating Agents (ESA)

ACTIVE COMPARATOR

Drug: ESA

Interventions

AND017 capsules DRUG

AND017 capsules administered orally with a starting dose of 10 mg TIW

AND017

ESA DRUG

ESA injection and dose based on package insert and local practice

Erythropoiesis Stimulating Agents (ESA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kind Pharmaceuticals LLC: lead

Study Sites (1)

Fudan Univeristy Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yusha Zhu, MD, PhD

  Kind Pharmaceuticals LLC

  STUDY DIRECTOR

Central Study Contacts

Yusha Zhu, MD, PhD

CONTACT

6467252552; yushazhu@kindpharmaceutical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)