Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 7:23 AM
Study NCT ID:
NCT06720233
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2024-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of SAL-0951 in the Treatment of Renal Anemia in Patients Receiving Peritoneal Dialysis
Sponsor:
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase III, Multicenter, Open-label, Single-arm Clinical Study to Evaluate the Efficacy and Safety of SAL-0951 Tablets in the Treatment of Renal Anemia in Patients With Chronic Kidney Disease Receiving Maintenance Peritoneal Dialysis
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of SAL-0951 in Chinese patients receiving peritoneal dialysis with chronic kidney disease and anemia
Detailed Description:
This is a multicenter, open-label, single-arm clinical study (using individualized dose adjustment design). Eligible subjects after screening will be assigned to the test group for a 24-week treatment to verify the efficacy and safety of SAL-0951 in the treatment of renal anemia in patients receiving peritoneal dialysis.
The study is mainly divided into four stages: screening period (2 or 4 weeks before administration), initial treatment period (4 weeks), maintenance treatment period (20 weeks), and safety follow-up period (2 weeks), requiring a total of 11 visits. This study includes the 24th week visit as the end of treatment visit (EOT) and the 26th week as the end of study visit (EOS). Subjects who withdraw early will be required to complete the research procedure for Week 24.
The study is mainly divided into four stages: screening period (2 or 4 weeks before administration), initial treatment period (4 weeks), maintenance treatment period (20 weeks), and safety follow-up period (2 weeks), requiring a total of 11 visits. This study includes the 24th week visit as the end of treatment visit (EOT) and the 26th week as the end of study visit (EOS). Subjects who withdraw early will be required to complete the research procedure for Week 24.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: