A Phase 1 interventional study of HEC53856 in Hemodialysis and Peritoneal Dialysis, sponsored by Sunshine Lake Pharma Co., Ltd.. Completed at 7 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Sunshine Lake Pharma Co., Ltd. · Phase 1, Interventional, and Treatment
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HEC53856 capsules on anemia in subjects with chronic kidney disease on dialysis.
The purpose of this multicenter, open-label, dose-increasing, multiple-dose study was to evaluate the safety, tolerability,PK and preliminary efficacy of HEC53856 capsules in renal anemia subjects on dialysis.
The study consists of two parts, hemodialysis or peritoneal dialysis . Within each part participants will be administrated for HEC53856.
There are three study periods:
Screening period :up to 2weeks; Treatment period: 6 weeks(except that 7 weeks in the 100mg cohort in the hemodialysis); Follow-up period: 2weeks.
Sunshine Lake Pharma Co., Ltd. is the lead sponsor of 82 studies on the registry; 13 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Those who have any of the following heart/cerebrovascular diseases:
Those who have any of the following medical or surgical history:
g) Anyone who has participated or plans to participate in an organ transplant within 6 months; h) Have a history of chronic liver disease (such as: chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis Or liver fibrosis); i) Patients with a history of polycystic kidney disease.
Any of the following laboratory abnormalities during the screening period:
HEC53856 Oral TIW There will be a total of 3 dose cohorts in the hemodialysis: 100mg,150mg,200mg; There will be only one dose cohort in the peritoneal dialysisp:100mg.
Drug: HEC53856
The 100mg dose cohort in the hemodialysis: D1 single oral administration of the investigation product 2.5h before hemodialysis; Three times a week for 6 weeks starting from D8, oral administration of the test drug 2.5h after hemodialysis. The rest dose cohorts in the hemodialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product 2.5h after hemodialysis. The dose cohort in the peritoneal dialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product after fasting.
Incidence of Adverse Events
To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule
Time frame: Up to 2 weeks after last dose
AUC0-t
Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Time frame: Up to 72 hours after single and multiple drug dosing
Cmax
Maximum observed plasma concentration
Time frame: Up to 72 hours after single and multiple drug dosing
Tmax
Time of the maximum observed plasma concentration
Time frame: Up to 72 hours after single and multiple drug dosing
T½
Apparent terminal elimination half-life
Time frame: Up to 72 hours after single and multiple drug dosing
Vz/F
Apparent volume of distribution
Time frame: Up to 72 hours after single and multiple drug dosing
Changes in mean hemoglobin
Changes in mean hemoglobin (Hb) relative to baseline during visit 8 and 9.
Time frame: Up to 2 weeks after the last dose
Hemoglobin response
Percentage of subjects who met the hemoglobin response after dosing
Time frame: Up to 2 weeks after the last dose
E-AUC0-t
Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Time frame: Up to 72 hours after single and multiple drug dosing
Emax
Maximum observed EPO concentration
Time frame: Up to 72 hours after single and multiple drug dosing
E-Tmax
Time of the maximum observed EPO concentration
Time frame: Up to 72 hours after single and multiple drug dosing
Serum lipid
Changes in Serum lipid relative to baseline at visit 8.
Time frame: week 6
Indicators of iron
Changes in the Indicators of iron relative to baseline at visit 8
Time frame: week 6
High-sensitivity C-reactive protein
Changes in the High-sensitivity C-reactive protein relative to baseline at visit 8.
Time frame: week 6
Reticulocytes
Changes in the mean Reticulocytes relative to baseline after doses.
Time frame: Up to week 8
VEGF
Changes in the VEGF relative to baseline after doses.
Time frame: week 6
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Sunshine Lake Pharma Co., Ltd.