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

ConditionRenal Anemia in Non-dialysis Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

  • 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

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 2mg Enarodustat ESA-naïveExperimental treatment 1 intervention
Group B: 3mg Enarodustat ESA-naïveExperimental treatment 1 intervention
Group C: 4mg Enarodustat ESA-naïveExperimental treatment 1 intervention
Group D: 2mg Enarodustat ESA-treatedExperimental treatment 1 intervention
Group E: 3mg Enarodustat ESA-treatedExperimental treatment 1 intervention
Group F: 4mg Enarodustat ESA-treatedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Hb level at Week 16 of treatment

Time frame
week 16

Secondary outcomes

1

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

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

Cumulative proportion of subjects with Hb levels of ≥110 g/L and <130 g/L at each visit

Time frame
week 0,2,4,8,12,16
3

ESA-treated group: cumulative proportion of subjects with Hb levels ±10 g/L from baseline at Weeks 12-16 of treatment;

Time frame
week12- 16
4

Hb levels at each visit

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: