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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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.);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Hb level at Week 16 of treatment

Timeframe: week 16

Trial details

NCT IDNCT07079579

SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Xiangmei Chen, MD.&Ph.D

13501261896 Xmchen301@126.com

View on ClinicalTrials.gov More Renal Anemia in Non-dialysis Chronic Kidney Disease trials