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Enarodustat Tablets at Different Initial Doses for Anemia in Non-dialysis CKD Patients

NCT07079579 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-23

No results posted yet for this study

Summary

To evaluate the rationality of different initial doses of enarodustat for the treatment of anemia in ND-CKD patients

Conditions

  • Renal Anemia in Non-dialysis Chronic Kidney Disease

Interventions

DRUG

Enarodustat 2mg

initial phase：2mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

DRUG

Enarodustat 3mg

initial phase：3mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

DRUG

Enarodustat 4mg

initial phase：4mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

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
2025-08-31
Primary Completion
2027-06-30
Completion
2027-12-31

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 NCT07079579 on ClinicalTrials.gov