Anemia of Chronic Kidney DiseaseNCT07741279
Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
An observational study of Anemia of Chronic Kidney Disease and CKD, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease, CKD, Non-dialysis Chronic Kidney Disease
- What is being tested?
- Enarodustat
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2025to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Chen, PhD, MD contact
China1 site, 1 recruiting
- Recruiting
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
Mengjing Wang Huashan hospital, Fudan university, PhD, MD, 021-52889393, fiyona27@126.com
About this study
Official title: Real-World Research on Efficacy of Enarodustat in Patients With CKD-Associated Anemia
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.
Read the detailed description
Enarodustat is an oral HIF-PHI that elevates endogenous EPO to treat CKD-related anemia. Inflammation and iron disturbance interfere with its efficacy, while real-world stratified data for Chinese non-dialysis CKD patients remain scarce.
This single-center prospective cohort will recruit 90 patients equally divided into 3 groups by baseline CRP: normal (CRP ≤3 mg/L), mild inflammation (3<CRP ≤10 mg/L), moderate inflammation (CRP>10 mg/L). All subjects start enarodustat 4 mg qd, with dose adjusted 1-8 mg every 4 weeks to keep Hb 110-130 g/L. Iron supplements will be given for iron deficiency, and routine CKD medications stay stable.
Participants attend 6 visits over 24 weeks. Blood tests are performed every 4 weeks. Extended biomarkers tested at baseline, Week12 and Week24 include CBC, reticulocyte count, folate, vitamin B12, EPO, renal function, electrolytes, iPTH, iron profiles, hepcidin and CRP. UACR, vital signs, medication records, drug dose logs and all adverse events are recorded at each visit.
Primary endpoint: Hb change from baseline to Week24. Secondary endpoints cover Hb target control rate, early Hb elevation speed, longitudinal changes of reticulocytes, renal, electrolyte, bone mineral, nutritional, iron and inflammatory markers, plus total adverse event incidence. This study explores personalized enarodustat dosing under different inflammatory, iron and metabolic backgrounds.
- Being tested
- Enarodustat
- Keywords
- Enarodustat, HIF-PHI, Renal anemia, Inflammation, Real-world study, Iron metabolism
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnarodustatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Enarodustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (Hb) from baseline to Week 24
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
Measured: 24 weeks after enrollment
Secondary outcomes (5)
Hemoglobin control rate at each follow-up visit
Proportion of participants achieving target hemoglobin (110-130 g/L) at Week 4, 8, 12, 16, 20, 24
Measured: Week 4, 8, 12, 16, 20, 24
Hemoglobin rising rate within the first 4 weeks
Average Hb increase rate (g/L per month) during the first 4 weeks of treatment, stratified by baseline CRP and ferritin
Measured: Baseline to Week 4
Changes in iron metabolism and inflammatory biomarkers
Changes of ferritin, TSAT, serum iron, hepcidin and CRP from baseline to Week 12 and Week 24
Measured: Week 12, Week 24
Dynamic changes of routine blood parameters
Changes in RBC, Hct, MCV, RDW at each 4-week follow-up
Measured: Week 4, 8, 12, 16, 20, 24
Incidence of adverse events and serious adverse events
Proportion of participants experiencing any adverse event (AE) or serious adverse event (SAE) during the 24-week observation period
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start23 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, PhD, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741279
- Sponsor's protocol ID
- KY-2024-1391
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon request pending