Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502537
Status:
UNKNOWN
Last Update Posted:
2021-01-22
First Post:
2020-08-03
Brief Title:
Roxadustat for Anemia in Patients With CKD
Sponsor:
Shenzhen Second Peoples Hospital
Organization:
Shenzhen Second Peoples Hospital
Study Overview
Official Title:
A Prospective Cohort Study of Roxadustat for Anemia in Patients With Chronic Kidney Disease
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia but there is a lack of evidence from cohort studies A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world
Detailed Description:
The prevalence of anemia in patients with chronic kidney disease CKD 154 is twice that of the general population 76 and the degree of anemia increases with the severity of CKD A number of RCT studies have shown the safety and effectiveness of oral Roxadustat in the treatment of renal anemia but there is a lack of evidence from cohort studies A prospective cohort study is planed to conduct to evaluate the efficacy and safety of Roxadustat for renal anemia in the real world It is planned to continuously recruit patients with renal anemia in Shenzhen Second Peoples Hospital from October 2020 to June 2023 The treatment of anemia will be recorded Roxadustat or erythropoietin and the observation period is one year Collect the patients demographic characteristics drug dosage adjustment plan hemoglobin The main outcome indicators were the average change in Hb from baseline to 28-52 weeks and the Hb response rate reached during two consecutive visits the secondary outcome indicators were the maintenance rate of the target Hb level iron metabolism indicators 0 to 8 weeks of Hb level increase rate dose adjustment and safety indicators The generalized additive mixed model of repeated measures was used to analyze the changes and differences of outcome indicators in different groups Expected results In the cohort study the effectiveness and safety of roxastat in the treatment of renal anemia the starting dose and the adjustment plan provide a basis for guiding the clinical safe and effective application of roxastat
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None