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

Hemodialysis Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04925674
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date September 29, 2021
Completion date January 14, 2023
View Details
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