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

NCT07487727 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-03-27

No results posted yet for this study

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

Interventions

DRUG

AND017

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

DRUG

ESA

ESA injection and dose based on package insert and local practice

Sponsors & Collaborators

  • Kind Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Yusha Zhu, MD, PhD · Kind Pharmaceuticals LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2026-12-01
Completion
2027-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07487727 on ClinicalTrials.gov