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

NCT07487727 | Recruiting Phase 3

• 1 other identifier: AND017-CN-301
• Study Type: interventional
• Target: 240
• 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 non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment

Conditions

Anemia Due to Chronic Kidney Disease

Keywords

anemia; CKD

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of AND017 compared with the active control in maintaining Hemoglobin (Hb) levels in patients with anemia due to CKD

  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

Erythropoiesis Stimulating Agents (ESA)

ACTIVE COMPARATOR

Drug: ESA

Interventions

AND017 DRUG

AND017 capsules administered orally with a starting dose of 8 mg TIW for ESA naive patients or 10 mg TIW for ESA treated patients

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:

• A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.
• Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.
• Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment
• ESA/HIF-PHI-naïve: Defined as no use of any ESA/HIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g/dL and \<10.0 g/dL with a difference of ≤1.3 g/dL between the two values;
• ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g/dL inclusive.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3× upper limit of normal (ULN)
• Transferrin saturation (TSAT) ≥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/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)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, 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

646-725-2552; 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 17, 2026
• First Posted: March 23, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)