Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466785
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Brief Title:
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Sponsor:
Genexine Inc
Organization:
Genexine Inc
Study Overview
Official Title:
A Phase III Randomized Investigator-Blinded Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
An investigator-blinded randomized multicenter active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis
Detailed Description:
This is an investigator-blinded randomized multicenter active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis Eligible patients will be randomized to efepoetin alfa or darbepoetin alfa at a ratio of 21 An unblinded team will prepare and administer the study drug at the dosages decided by the blinded Investigator
The study consists of 3 study periods
Screening up to 28 days before Day 1 subjects in screening will continue treatment with epoetin methoxy polyethylene glycol-epoetin beta or darbepoetin alfa as per local standard of care
Treatment subjects will discontinue any prior erythropoietin analogue and will be randomized to switch to efepoetin alfa or darbepoetin alfa in a 21 ratio
The aim of the treatment period is to maintain Hb levels between 100 gdL and 120 gdL It is recommended that study treatment be administered any time after completion of dialysis if dosing is scheduled on a dialysis day to avoid potential bias on study assessments
Follow-up 4 weeks Phone contacts can be done for follow-up for up to Week 56 or at the time of the last patients Week 56 visit whichever is shorter
The study consists of 3 study periods
Screening up to 28 days before Day 1 subjects in screening will continue treatment with epoetin methoxy polyethylene glycol-epoetin beta or darbepoetin alfa as per local standard of care
Treatment subjects will discontinue any prior erythropoietin analogue and will be randomized to switch to efepoetin alfa or darbepoetin alfa in a 21 ratio
The aim of the treatment period is to maintain Hb levels between 100 gdL and 120 gdL It is recommended that study treatment be administered any time after completion of dialysis if dosing is scheduled on a dialysis day to avoid potential bias on study assessments
Follow-up 4 weeks Phone contacts can be done for follow-up for up to Week 56 or at the time of the last patients Week 56 visit whichever is shorter
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?:
None
Is an FDA AA801 Violation?:
None