Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352138
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-11
Brief Title:
Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Sponsor:
Megalabs
Organization:
Megalabs
Study Overview
Official Title:
Phase III Multicentre Double-blind Randomised Parallel Equivalence Clinical Trial to Assess Efficacy Safety of Megalabs Recombinant iv Human Erythropoietin Compared to Epogen in Anaemia in Patients With Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
ENCASE
Brief Summary:
Phase III multicentre double-blind randomised parallel equivalence clinical trial to determine the efficacy safety and immunogenicity of Megalabs recombinant human alfa epoetin for intravenous use compared to Epogen in the treatment of anaemia in participants with chronic renal disease dependent on haemodialysis
Detailed Description:
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia Hemoglobin hematocrit and reticulocyte counts will be assessed Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination Test drug and comparator drug will be compared to evaluate biosimilarity
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