Iron Sucrose in Stage 3/4 Kidney Disease

NCT ID: NCT00202345

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-02-28

Brief Summary

One of the complications of late stage kidney disease is the development of a low red blood cell count (anaemia/low 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.

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 500µg/L and/or 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 150µg/L and/or 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.

Conditions

Kidney Failure; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Iron sucrose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Initial Hb concentrations ≥ 110g/L (males and females)

2. Calculated GFR ≤ 35mL/min (≤ 50mL/min for diabetics)

3. Demonstration of a clinically significant rise in creatinine and/or a drop in Hb concentration in the previous 18 months. If such data are not available, the investigator will make a decision regarding eligibility based on the clinical circumstances.

Exclusion Criteria

1. Age > 80

2. Pregnancy*

3. Unstable ischaemic heart disease*

4. Uncontrolled, severe, congestive cardiac failure

5. Haemochromatosis or iron overload* (ferritin >300µg/L and TSAT >25%)

6. Liver failure

7. Myelodysplastic syndromes or monoclonal gammopathies

8. Active malignancy or gastrointestinal bleeding*

9. Persistent sepsis* or significant chronic inflammation (CRP > 25)*

10. Iron deficiency* (Ferritin <30ug/L and Tsat <15%)or other haematinic disorder

11. Active and significant haemolysis*

12. Previous organ transplantation

13. Concurrent or significant past (>6 months) immuno-suppression

14. Adult polycystic kidney disease

15. Current use of an ESA

16. On dialysis *: patients can still be considered eligible after condition is reversed or treated

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Melbourne Health

OTHER

Sponsor Role: lead

Principal Investigators

Lawrence P McMahon, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Central Coast Health

Gosford, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Countries

Australia

Other Identifiers

Iron Sucrose 61864

Identifier Type: -

Identifier Source: org_study_id