Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202345
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2005-09-15
Brief Title:
Iron Sucrose in Stage 34 Kidney Disease
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
Assessment of the Use of Intravenous Iron Sucrose to Maintain Haemoglobin Levels and Delay the Onset of Use of Erythropoietic Agents andor Dialysis in Stage 34 Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2015-05
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:
One of the complications of late stage kidney disease is the development of a low red blood cell count anaemialow haemoglobin concentration The Australian Commonwealth government limits funding of medications called erythropoietic stimulating agents to those patients who have already developed anaemia
There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in these patients Higher haemoglobin can delay the onset of dialysis and reduce the development of heart enlargement However the administration of erythropoietic stimulating agents is not without risk including a high financial burden worsening of high blood pressure and a rare complication called pure red cell aplasia
Previous studies have shown that patients with chronic kidney disease require additional iron to maintain the production of red blood cells Thus it would be timely to determine if the administration of iron sucrose to these patients can maintain a near normal haemoglobin concentration without the need to start an erythropoietic stimulating agent and possibly delaying dialysis
Study Hypothesis That administration of iron sucrose is superior to standard care in the prevention of anaemia in patients with stage 3 4 kidney disease
There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in these patients Higher haemoglobin can delay the onset of dialysis and reduce the development of heart enlargement However the administration of erythropoietic stimulating agents is not without risk including a high financial burden worsening of high blood pressure and a rare complication called pure red cell aplasia
Previous studies have shown that patients with chronic kidney disease require additional iron to maintain the production of red blood cells Thus it would be timely to determine if the administration of iron sucrose to these patients can maintain a near normal haemoglobin concentration without the need to start an erythropoietic stimulating agent and possibly delaying dialysis
Study Hypothesis That administration of iron sucrose is superior to standard care in the prevention of anaemia in patients with stage 3 4 kidney disease
Detailed Description:
Eligible patients will be approached Those who agree to partake in the study will after enrolment including informed consent be randomized to one of 2 groups
Group A To receive intravenous iron sucrose to maintain supra-physiological measures of iron status Group A will be targeted to have ferritin levels between 300 and 500µgL andor a transferrin saturation of between 25 and 50 Between 100 and 200mg of intravenous iron sucrose will be administered by slow bolus injection one- to two-monthly to achieve these levels
Oral iron will not be used routinely in this group
Group B Will have oral iron therapy if required to maintain ferritin levels between 100 and 150µgL andor transferrin saturations 20 but 25 Patients in Group B who are unable to tolerate oral iron will be administered iron sucrose if necessary to maintain acceptable iron levels
Patients in Group B will therefore differ from those in Group A a through the routine use of iron sucrose and b through the maintenance of different ferritin and transferrin saturation levels
Group A To receive intravenous iron sucrose to maintain supra-physiological measures of iron status Group A will be targeted to have ferritin levels between 300 and 500µgL andor a transferrin saturation of between 25 and 50 Between 100 and 200mg of intravenous iron sucrose will be administered by slow bolus injection one- to two-monthly to achieve these levels
Oral iron will not be used routinely in this group
Group B Will have oral iron therapy if required to maintain ferritin levels between 100 and 150µgL andor transferrin saturations 20 but 25 Patients in Group B who are unable to tolerate oral iron will be administered iron sucrose if necessary to maintain acceptable iron levels
Patients in Group B will therefore differ from those in Group A a through the routine use of iron sucrose and b through the maintenance of different ferritin and transferrin saturation levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None