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

NCT04925674 | Completed Phase 1

• 1 other identifier: HEC53856-RAD-103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Hemodialysis; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 2 weeks after last dose

Secondary Outcomes (15)

• AUC0-t

  Up to 72 hours after single and multiple drug dosing

• Cmax

  Up to 72 hours after single and multiple drug dosing

• Tmax

  Up to 72 hours after single and multiple drug dosing

• T½

  Up to 72 hours after single and multiple drug dosing

• Vz/F

  Up to 72 hours after single and multiple drug dosing

Study Arms (1)

HEC53856

EXPERIMENTAL

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

Interventions

HEC53856 DRUG

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.

HEC53856

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject voluntarily participated in this clinical trial and signed an informed consent form;
• 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.

You may not qualify if:

• 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;
• history of malignant tumor within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ), or current assessment of potential malignant tumor;
• suffering Uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH\>800pg/ml;
• History of dysphagia or any gastrointestinal disease that affects drug absorption, history of gastric/jejunum/colon resection; f ) Those who have a serious infection and are receiving systemic antibiotic treatment;
• 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:
• Folic acid \<6.8nmol/L (3ng/ml) and/or VitB12\<74pmol/L (100ng/ml);
• Serum albumin \<3 g/dL;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead
• Nicoya Therapeutics (Shanghai) Co., Ltd.: collaborator

Study Sites (7)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Sichuan Provincial People's Hospital

Chengdu, China

Location

The First Affiliated Hospital of Shantou University Medical College

Shantou, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

General Hospital of Tianjin Medical University

Tianjin, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, China

Location

The Fifth Affiliated Hospital Sun Yat-sen University

Zhuhai, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 14, 2021
• Study Start: September 10, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: May 15, 2025

Record last verified: 2021-06

Locations

CN (7)