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Study of SAL-0951 Compared to Recombinant Human Erythropoietin in Anemic Patients Receiving Maintenance Hemodialysis

NCT06720025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in Chinese patients undergoing maintenance hemodialysis with chronic kidney disease and anemia，who are receiving stable treatment with erythropoietic stimulants (ESAs).

Conditions

Interventions

DRUG

SAL-0951 tablets

initial phase：4mg QD subsequent phase：1mg～8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks

DRUG

rHuEPO injection

Initial based on the original rHuEPO dose adjust the dose based on hemoglobin concentration level every 4 weeks

Sponsors & Collaborators

  • Shenzhen Salubris Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Chen, Ph.D · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-06-17
Completion
2024-06-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720025 on ClinicalTrials.gov