CompletedPhase 1

Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.

China60 participantsStarted 2021-09-10

Plain-language summary

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HEC53856 capsules on anemia in subjects with chronic kidney disease on dialysis.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. The subject voluntarily participated in this clinical trial and signed an informed consent form;
✓. 18-70 years old, weight 45\~90kg, including cut-off value;
✓. Hemodialysis (Hemodialysis, HD): Patients with end-stage renal disease who are on stable dialysis receive 3 times a week hemodialysis for at least 3 months before screening, and can receive 3 times a week hemodialysis at regular intervals during the test. The duration of the subject's hemodialysis treatment must be 3-4.5 hours (including the cut-off value); Peritoneal dialysis: For patients with end-stage renal disease on stable dialysis, the subject must receive peritoneal dialysis for at least 3 months before screening;
✓. Subjects stop EPO 14 days or 5 half-lives (whichever is the longest) before taking the test drug for the first time;
✓. Subjects have stable dialysis methods and dialysis prescriptions, and are expected to have no major treatment changes or no drastic changes in their condition during the clinical trial period;
✓. During the screening period, the hemoglobin value obtained by the two tests of Visit 1 and Visit 2 must be \> or = 8.0 g/dL and \<11.0 g/dL, and the difference between the two must be \< or = 1.5 g/dL.

Exclusion criteria

✕. Existence of past medical history or conditions that may cause anemia other than nephropathy, including but not limited to blood system diseases, such as thalassemia, aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.; Autoimmune diseases that may affect red blood cell production, such as systemic lupus erythematosus, rheumatoid arthritis, etc.; Bleeding diseases, such as gastrointestinal bleeding, obstetrics and gynecology bleeding diseases, etc.
✕. During the study period, those who plan to change the dialysis method/mode or the flux of the hemodialysis machine, such as changing from peritoneal dialysis to hemodialysis
✕. Those who have any of the following heart/cerebrovascular diseases:
✕. Acute coronary syndrome, stroke (except lacunar infarction) or thromboembolic disease (such as deep vein thrombosis or pulmonary embolism) occurred within 6 months before screening;
✕. Heart Function III of New York Society of Cardiology Or grade IV congestive heart failure, or severe arrhythmia, including but not limited to ventricular tachycardia, ventricular fibrillation, III degree atrioventricular block, etc.
✕. Those who have any of the following medical or surgical history:
✕. Those who plan to undergo major surgery 3 months before screening or during the study period (except for hemodialysis access repair) or blood transfusion therapy;
✕. Have peritoneal dialysis related 3 months before screening Peritonitis, history of infection or leakage of peritoneal tube tunnel;

What they're measuring

Incidence of Adverse Events

Timeframe: Up to 2 weeks after last dose

Trial details

NCT IDNCT04925674

SponsorSunshine Lake Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-19

View on ClinicalTrials.gov More Hemodialysis trials