Not Yet RecruitingPhase 4

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

China120 participantsStarted 2025-08

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged 18-75 years (inclusive);
✓. Body weight: 45-100 kg (inclusive);
✓. Stage 3-5 non-dialysis CKD complicated with renal anemia during the screening period, with an eGFR of 10-60 mL/min/1.73 m2 (exclusive) (calculated by CKD-EPI equation);
✓. Criteria for Hb levels at screening and baseline
✓. ESA-naïve population: Patients who do not receive ESA treatment in the past 12 weeks, with the Hb level greater than or equal to 70 g/L and less than 100 g/L;
✓. ESA-treated population: Patients who have received ESA treatment for at least 8 weeks, with the Hb level greater than or equal to 100 g/L and less than or equal to 120 g/L; 5.Female patients shall take contraceptive measures during the study; Patients who voluntarily participate in the study and sign the informed consent form.

✕. Patients with SF ≤100 μg/L and TSAT ≤20% at screening;
✕. Patients who are expected to start renal replacement therapy in the next 6 months as judged by the investigator;
✕. Patients with systemic hematologic disorders (e.g., myelodysplastic syndrome and aplastic anemia, etc.) or non-CKD-related anemia (hemolytic anemia, hemorrhagic anemia, cancer related anemia, etc.);
✕. Patients with a 1.5-fold increase in serum creatinine during the screening period;
✕. Patients who have received hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) within 8 weeks before screening;
✕. Patients with polycystic kidney disease;
✕. Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at the screening visit);
✕. Patients with congestive cardiac failure (New York Heart Association \[NYHA\] Class III or above) or unstable angina;

Mean Hb level at Week 16 of treatment

Timeframe: week 16

NCT IDNCT07079579

SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Xiangmei Chen, MD.&Ph.D

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged 18-75 years (inclusive);
✓. Body weight: 45-100 kg (inclusive);
✓. Stage 3-5 non-dialysis CKD complicated with renal anemia during the screening period, with an eGFR of 10-60 mL/min/1.73 m2 (exclusive) (calculated by CKD-EPI equation);
✓. Criteria for Hb levels at screening and baseline
✓. ESA-naïve population: Patients who do not receive ESA treatment in the past 12 weeks, with the Hb level greater than or equal to 70 g/L and less than 100 g/L;
✓. ESA-treated population: Patients who have received ESA treatment for at least 8 weeks, with the Hb level greater than or equal to 100 g/L and less than or equal to 120 g/L; 5.Female patients shall take contraceptive measures during the study; Patients who voluntarily participate in the study and sign the informed consent form.

✕. Patients with SF ≤100 μg/L and TSAT ≤20% at screening;
✕. Patients who are expected to start renal replacement therapy in the next 6 months as judged by the investigator;
✕. Patients with systemic hematologic disorders (e.g., myelodysplastic syndrome and aplastic anemia, etc.) or non-CKD-related anemia (hemolytic anemia, hemorrhagic anemia, cancer related anemia, etc.);
✕. Patients with a 1.5-fold increase in serum creatinine during the screening period;
✕. Patients who have received hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) within 8 weeks before screening;
✕. Patients with polycystic kidney disease;
✕. Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at the screening visit);
✕. Patients with congestive cardiac failure (New York Heart Association \[NYHA\] Class III or above) or unstable angina;