Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
2026年7月28日 更新者：Chen Jing、Huashan Hospital
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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (推定)
90
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mengjing Wang, PhD, MD
- 電話番号：02152889393
- メール：fiyona27@126.com
研究連絡先のバックアップ
- 名前：Jing Chen, PhD, MD
研究場所
-
-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200040
- 募集
- Huashan Hospital, Fudan University
-
コンタクト：
- Mengjing Wang Huashan hospital, Fudan university, PhD, MD
- 電話番号：021-52889393
- メール：fiyona27@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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)
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.
|
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.
|
|
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in hemoglobin (Hb) from baseline to Week 24
時間枠：24 weeks after enrollment
|
Difference in hemoglobin concentration between Week 24 and baseline, measured by routine venous blood test.
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24 weeks after enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hemoglobin control rate at each follow-up visit
時間枠：Week 4, 8, 12, 16, 20, 24
|
Proportion of participants achieving target hemoglobin (110-130 g/L) at Week 4, 8, 12, 16, 20, 24
|
Week 4, 8, 12, 16, 20, 24
|
|
Hemoglobin rising rate within the first 4 weeks
時間枠：Baseline to Week 4
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Average Hb increase rate (g/L per month) during the first 4 weeks of treatment, stratified by baseline CRP and ferritin
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Baseline to Week 4
|
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Changes in iron metabolism and inflammatory biomarkers
時間枠：Week 12, Week 24
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Changes of ferritin, TSAT, serum iron, hepcidin and CRP from baseline to Week 12 and Week 24
|
Week 12, Week 24
|
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Dynamic changes of routine blood parameters
時間枠：Week 4, 8, 12, 16, 20, 24
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Changes in RBC, Hct, MCV, RDW at each 4-week follow-up
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Week 4, 8, 12, 16, 20, 24
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|
Incidence of adverse events and serious adverse events
時間枠：Baseline to Week 24
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Proportion of participants experiencing any adverse event (AE) or serious adverse event (SAE) during the 24-week observation period
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Baseline to Week 24
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jing Chen, PhD, MD、Huashan Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年3月23日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年7月28日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月3日
QC基準を満たした最後の更新が送信されました
2026年7月28日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。