Iron Sucrose in Stage 3/4 Kidney Disease

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

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