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

NCT07079579 | Not Yet Recruiting Phase 4

• 1 other identifier: SAL0951A401
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Anemia in Non-dialysis Chronic Kidney Disease

Keywords

Renal Anemia in Non-dialysis Chronic Kidney Disease; Enarodustat

Outcome Measures

Primary Outcomes (1)

• Mean Hb level at Week 16 of treatment

  week 16

Secondary Outcomes (6)

• Cumulative proportion of subjects with Hb levels of ≥100 g/L and ≤120 g/L at each visit

  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

  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;

  week12- 16

• Hb levels at each visit

  week 0,2,4,8,12,16

• Change in Hb level from baseline at each visit

  week 0,2,4,8,12,16

Study Arms (6)

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

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

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

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

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

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

Drug: Enarodustat 4mg

Interventions

Enarodustat 2mg DRUG

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

2mg Enarodustat ESA-naïve; 2mg Enarodustat ESA-treated

Enarodustat 3mg DRUG

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

3mg Enarodustat ESA-naïve; 3mg Enarodustat ESA-treated

Enarodustat 4mg DRUG

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

4mg Enarodustat ESA-naïve; 4mg Enarodustat ESA-treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
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• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

enarodustat

Central Study Contacts

Xiangmei Chen, MD.&Ph.D

CONTACT

13501261896; Xmchen301@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)