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RECRUITING
NCT07487727
PHASE3

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

Sponsor: Kind Pharmaceuticals LLC

View on ClinicalTrials.gov

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

Official title: A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-12-03

Completion Date

2027-07-01

Last Updated

2026-03-27

Healthy Volunteers

No

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

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China