Enarodustat Tablets at Different Initial Doses for Anemia in Non-dialysis CKD Patients
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
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
Treatments tested in this trial
- Enarodustat 2mg
- Enarodustat 3mg
- Enarodustat 4mg
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov