NCT07494409

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kind Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	AND017 capsules	AND017 capsules administered orally with a starting dose of 10 mg TIW
DRUG	ESA	ESA injection and dose based on package insert and local practice

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-10-30
• Completion: 2027-04-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China