CompletedPhase 1

HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia

China40 participantsStarted 2021-11-04

Plain-language summary

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Patients who agree to participate in this clinical trial and sign an informed consent form;
✓. Age 18\~65 years old; Weight 40\~90Kg, including critical value;
✓. Glomerular filtration rate (eGFR) calculated by CKD-EPI formula 15mL/min/1.73 m\^2 \< or = eGFR \< 60 mL/min/1.73 m\^2 diagnosed chronic kidney disease patients who have not received dialysis;
✓. The hemoglobin values obtained during the last two screening periods at least 6 days apart must be \> or = 8.0 g/dL and \<10 g/dL.

Exclusion criteria

✕. Existence of diseases or conditions other than nephropathy that may cause anemia, including but not limited to 1) blood system diseases, such as thalassemia, aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.; 2) may affect red blood cells The resulting autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, etc.; 3) Bleeding diseases, such as gastrointestinal bleeding, obstetrics and gynecology bleeding diseases, etc.; 4) Elective surgery expected during the study period;
✕. Drugs used to treat anemia within 8 weeks before the first administration, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor prolyl hydroxylase inhibitors (HIF-PHI), androgens And anabolic hormone drugs, intravenous iron, Chinese patent medicine, Chinese herbal medicine, etc. (Can accept patients who have used a fixed dose of oral iron within 4 weeks before screening, and continue to take it during the screening period and the first 4 weeks after starting to take the test drug The fixed dose remains unchanged.);
✕. Those who have received blood transfusion within 3 months before the first administration;
✕. Folic acid \<6.8nmol/L (3ng/ml) and (or) VitB12\<74pmol/L (100ng/ml) during the screening period;
✕. Clinically significant chronic liver and gallbladder disease, or obvious abnormal liver function: ALT\>3×ULN and/or AST\>3×ULN, or total bilirubin\>1.5×ULN;
✕. Serum albumin \<3 g/dL;
✕. The mean systolic blood pressure \> or = 160 mmHg and/or the diastolic blood pressure \> or = 100 mmHg of the two blood pressure measurements at least one hour apart during the screening period;
✕. Suffering from uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH \> 500pg/ml;

What they're measuring

Incidence of Adverse Events

Timeframe: Through study completion, an average of 12 weeks.

Trial details

NCT IDNCT04925661

SponsorSunshine Lake Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-29

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