NCT04925674

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

Phase Ic Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Subjects With Renal Anemia on Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hemodialysis
• Peritoneal Dialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-10
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2021-06-14
• Last updated: 2025-05-15

Locations

7 sites across 1 country: China