Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03610230
Status:
TERMINATED
Last Update Posted:
2021-10-06
First Post:
2018-05-31
Brief Title:
Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 Monofer Compared With Iron Sucrose Venofer in Peritoneal Dialysis Patients
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficult patient recruitment due to COVID-19 epidemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 To compare patient-reported satisfaction efficacy and short-term safety profile of Monofer in a single bolus dose with Venofer in split doses in the treatment of absolute or functional iron deficiency anemia in patients on PD
2 To compare patient symptomatology on fatigue after treatment of Monofer compared with Venofer
2 To compare patient symptomatology on fatigue after treatment of Monofer compared with Venofer
Detailed Description:
Anemia is commonly present in patients with end-stage renal failure ESRF due to insufficient endogenous erythropoietin production absolute and functional iron deficiency With the introduction of recombinant human erythropoietin rHuEPO and the accessibility of rHuEPO to dialysis patients in the Hospital Authority Drug Formulary blood transfusion requirement for the treatment of renal related anemia has been much reduced However iron store must also be adequately maintained for effective erythropoiesis The latest KDIGO guideline for anemia in chronic kidney disease recommends iron therapy either in oral or intravenous form if TSAT is 30 and ferritin is 500µgL Oral iron supplement is the most convenient but it is less effective compared to intravenous forms especially in the treatment of functional iron deficiency and has unfavorable patient tolerability and gastro-intestinal side-effect profiles Iron sucrose Venofer is the most widely used intravenous iron preparation with good safety profile An initial course of intravenous iron eg Venofer 200mg weekly for 5 weeks is commonly given to iron-deplete patients before consideration of maintenance iron therapy The absence of a vascular access and the need to return to hospital facilities for regular intravenous infusions made intravenous forms less preferred by patients on peritoneal dialysis PD Isomaltoside 1000 Monofer consists of iron with a tighter binding to its carbohydrate moiety with less free iron to cause immunologic reactions and thus allowing for a larger single-dose administration This may facilitate better acceptance of intravenous iron by patients on PD The current literature on the efficacy and safety profile of Monofer in the treatment of renal-related anemia focus mainly on patients on hemodialysis and patients with non-dialysis dependent chronic kidney disease There is also a lack of information on patient-reported satisfaction on the use of Monofer The objective of the current study is to investigate patient-reported satisfaction efficacy and short-term safety profile of a single bolus of Monofer compared to Venofer in the treatment of both absolute and functional iron deficiency anemia in patients on PD In the second part of the study patients with recurrent iron deficiency will be crossed-over to receive treatment of the alternative arm Similar to the first part of the study patient-reported satisfaction and treatment efficacy will be compared following the same study protocol
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