Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients

NCT07741279 | Recruiting DMC

• 1 other identifier: KY-2024-1391
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective real-world observational study aiming to evaluate the efficacy and safety of oral enarodustat in adult non-dialysis chronic kidney disease (ND-CKD) patients with renal anemia. A total of 90 eligible participants will be enrolled and stratified into three groups according to baseline C-reactive protein (CRP) levels: CRP ≤3 mg/L, 3\<CRP ≤10 mg/L, and CRP\>10 mg/L. All subjects receive routine oral enarodustat treatment with individualized dose titration, together with standard supportive care for CKD. Each participant will be followed up every 4 weeks for a total of 24 weeks. The primary objective is to compare the change in hemoglobin from baseline to week 24 across different inflammation subgroups. Secondary objectives include analyzing dynamic changes of iron metabolism indicators and documenting all adverse events during treatment. This study will explore the optimal individualized dosing strategy of enarodustat under different inflammatory and iron status.

Conditions

CKD; Non-dialysis Chronic Kidney Disease; Anemia of Chronic Kidney Disease

Keywords

Enarodustat; HIF-PHI; Renal anemia; Inflammation; Real-world study; Iron metabolism

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin (Hb) from baseline to Week 24

  Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.

  24 weeks after enrollment

Secondary Outcomes (5)

• Hemoglobin control rate at each follow-up visit

  Week 4, 8, 12, 16, 20, 24

• Hemoglobin rising rate within the first 4 weeks

  Baseline to Week 4

• Changes in iron metabolism and inflammatory biomarkers

  Week 12, Week 24

• Dynamic changes of routine blood parameters

  Week 4, 8, 12, 16, 20, 24

• Incidence of adverse events and serious adverse events

  Baseline to Week 24

Study Arms (3)

Normal inflammation group (CRP ≤3 mg/L)

Participants with baseline serum CRP ≤3 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Drug: Enarodustat

Mild inflammation group (3<CRP ≤10 mg/L)

Participants with baseline serum CRP greater than 3 mg/L and ≤10 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Drug: Enarodustat

Moderate inflammation group (CRP>10 mg/L)

Participants with baseline serum CRP\>10 mg/L. All subjects receive oral enarodustat, initial dose 4 mg once daily, with dose adjusted between 1-8 mg every 4 weeks to maintain hemoglobin 110-130 g/L. Standard CKD supportive therapy and iron supplementation will be provided if iron deficiency exists.

Drug: Enarodustat

Interventions

Enarodustat DRUG

Oral enarodustat, starting dose 4 mg once daily. Dose can be titrated between 1 mg and 8 mg every 4 weeks to maintain hemoglobin within 110-130 g/L. Iron supplementation will be administered when iron deficiency is confirmed. Conventional chronic kidney disease medications are maintained as routine clinical practice.

Mild inflammation group (3<CRP ≤10 mg/L); Moderate inflammation group (CRP>10 mg/L); Normal inflammation group (CRP ≤3 mg/L)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult non-dialysis chronic kidney disease patients complicated with renal anemia who receive enarodustat treatment. Subjects are stratified by baseline CRP levels to evaluate treatment efficacy and safety.

You may qualify if:

• Aged 18-85 years, male or female;
• CKD-EPI eGFR \<60 mL/min/1.73m², stage 3-5 non-dialysis chronic kidney disease;
• Baseline hemoglobin ≥70 g/L and \<110 g/L, diagnosed with CKD-associated anemia;
• No plan for dialysis or kidney transplant within 24 weeks;
• Voluntary participation and signed written informed consent.

You may not qualify if:

• Severe infection, acute kidney injury, myocardial infarction, stroke, decompensated heart failure within recent 3 months;
• Malignancy, severe liver dysfunction (AST/ALT\>2.5 ULN, total bilirubin\>1.5 ULN), multiple organ failure;
• Autoimmune disease (lupus, vasculitis, rheumatoid arthritis) or chronic persistent infection (tuberculosis, fungal infection);
• Pregnant or breastfeeding women;
• Other causes of anemia (aplastic anemia, myelodysplastic syndrome, hemolytic anemia, active gastrointestinal bleeding);
• Poor compliance judged by investigator, unable to complete scheduled follow-up.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

enarodustat

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Chen, PhD, MD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengjing Wang, PhD, MD

CONTACT

02152889393; fiyona27@126.com

Jing Chen, PhD, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nephrology

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: March 23, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)