Renal Anemia in Non-dialysis Chronic Kidney DiseasePhase 4NCT07079579

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

A Phase 4 study testing Enarodustat 2mg, Enarodustat 3mg and Enarodustat 4mg in people with Renal Anemia in Non-dialysis Chronic Kidney Disease, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

To evaluate the rationality of different initial doses of enarodustat for the treatment of anemia in ND-CKD patients Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Renal Anemia in Non-dialysis Chronic Kidney Disease
What is being tested?: Enarodustat 2mg, Enarodustat 3mg and Enarodustat 4mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: Aug 2025to Dec 2027
Phase: Phase 4

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet all the following criteria can be enrolled in this study:
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.

Who cannot join

Patients who meet any one of the following criteria shall be excluded from the study:
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;

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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;
Patients who have experienced myocardial infarction, transient ischemic attack, cerebral infarction (except asymptomatic cerebral infarction) or venous thromboembolism (pulmonary embolism or deep vein thrombosis) from 24 weeks before screening to the first dose of the investigational drug;
Patients with severe hepatobiliary disorders (e.g., AST or ALT >2.5 × upper limit of normal (ULN) at the screening visit, patients with hepatic cirrhosis or total bilirubin ≥1.5 × ULN at the screening visit);
Patients who have received red blood cell transfusion from 12 weeks before screening to the first dose of the investigational drug;
Patients who have received growth hormone, thyroid hormone, testosterone enanthate or methandienone from 12 weeks before screening to the first dose of the investigational drug;
Patients who will undergo elective ophthalmic surgery in the next 6 months;
Patients with severe hyperparathyroidism (e.g., iPTH ≥500 pg/mL at the screening visit);
Patients with severe infections (e.g., active pulmonary tuberculosis and fungal infection, etc.);
Patients suspected of having other non-infectious chronic inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis and coeliac disease, etc.);
Patients with a positive result for HIV, HCV or Treponema pallidum antibody, or with a positive result for HBsAg and HBV DNA ≥1,000 U/mL;
Patients with a history of malignant tumors (including hematological malignancies) in the past 5 years;
Patients with a history of severe drug allergy (e.g., anaphylactic shock) or hypersensitivity to other HIF-PHIs;
Patients with a history of drug or alcohol abuse in the past two years;
Patients who have received other investigational drugs (or study drugs) or received investigational medical devices (or study devices) from 12 weeks before the screening visit to the first dose of the investigational drug, or are participating in other interventional clinical studies (medical behaviors beyond routine diagnosis and treatment, implemented for study purposes) and receiving treatment;
Patients who are pregnant, lactating or have the possibility of pregnancy (based on the results of the pregnancy test at the screening visit, the investigator cannot rule out the possibility of pregnancy);
Patients with any medical conditions that, in the investigator's judgment, may pose a safety risk, may confound efficacy or safety evaluation, or may interfere with their participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiangmei Chen, MD.&Ph.D contact

13501261896

Xmchen301@126.com

China1 site

Chinese PLA General Hosptial
Beijing, Beijing Municipality
Xiangmei Chen, MD.&Ph.D, 13501261896, Xmchen301@126.com

Other trials in China

About this study

Official title: A Prospective, Single-arm, Open-label Study to Evaluate Different Initial Doses of Enarodustat Tablets for the Treatment of Anemia in Patients With Non-dialysis Chronic Kidney Disease

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

Read the detailed description

The eligible subjects screened will be stratified by treatment history and randomized to the 2, 3, 4 mg dose groups in a 1:1:1 ratio. After receiving the initial doses of 2, 3, 4 mg/day for 4 weeks, the subjects will enter a 12-week maintenance treatment period with a total of 7 scheduled visits.

Conditions: Renal Anemia in Non-dialysis Chronic Kidney Disease
Being tested: Enarodustat 2mg, Enarodustat 3mg, Enarodustat 4mg
Keywords: Renal Anemia in Non-dialysis Chronic Kidney Disease, Enarodustat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enarodustat 2mgDrug
initial phase：2mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
Enarodustat 3mgDrug
initial phase：3mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
Enarodustat 4mgDrug
initial phase：4mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

Study groups in NCT07079579
Study group	Role	What they receive
2mg Enarodustat ESA-naïve	Experimental	ESA-naïve population initial phase：2mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 2mg
3mg Enarodustat ESA-naïve	Experimental	ESA-naïve population initial phase：3mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 3mg
4mg Enarodustat ESA-naïve	Experimental	ESA-naïve population initial phase：4mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 4mg
2mg Enarodustat ESA-treated	Experimental	ESA-treated population initial phase：2mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 2mg
3mg Enarodustat ESA-treated	Experimental	ESA-treated population initial phase：3mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 3mg
4mg Enarodustat ESA-treated	Experimental	ESA-treated population initial phase：4mg QD for 4 weeks subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks Receives: Drug: Enarodustat 4mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Hb level at Week 16 of treatment
Measured: week 16

Secondary outcomes (6)

Cumulative proportion of subjects with Hb levels of ≥100 g/L and ≤120 g/L at each visit
Measured: week 0,2,4,8,12,16
Cumulative proportion of subjects with Hb levels of ≥110 g/L and <130 g/L at each visit
Measured: week 0,2,4,8,12,16
ESA-treated group: cumulative proportion of subjects with Hb levels ±10 g/L from baseline at Weeks 12-16 of treatment;
Measured: week12- 16
Hb levels at each visit
Measured: week 0,2,4,8,12,16
Change in Hb level from baseline at each visit
Measured: week 0,2,4,8,12,16
Dosage of administration of the investigational drug throughout the treatment period
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2025Dec 2027

First posted23 Jul 2025
Study startAug 2025 (estimated)
Primary completionJun 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Anemia in Non-dialysis 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07079579
Sponsor's protocol ID: SAL0951A401
Status last verified: Jul 2025
First submitted: 6 Jul 2025
Last updated: 23 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Xiangmei Chen, MD.&Ph.D

13501261896

Xmchen301@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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