Status:
COMPLETED
Iron Sucrose in Stage 3/4 Kidney Disease
Lead Sponsor:
Melbourne Health
Conditions:
Kidney Failure
Anemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
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 iro...
Eligibility Criteria
Inclusion
- Initial Hb concentrations ≥ 110g/L (males and females)
- Calculated GFR ≤ 35mL/min (≤ 50mL/min for diabetics)
- 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
- Age \> 80
- Pregnancy\*
- Unstable ischaemic heart disease\*
- Uncontrolled, severe, congestive cardiac failure
- Haemochromatosis or iron overload\* (ferritin \>300µg/L and TSAT \>25%)
- Liver failure
- Myelodysplastic syndromes or monoclonal gammopathies
- Active malignancy or gastrointestinal bleeding\*
- Persistent sepsis\* or significant chronic inflammation (CRP \> 25)\*
- Iron deficiency\* (Ferritin \<30ug/L and Tsat \<15%)or other haematinic disorder
- Active and significant haemolysis\*
- Previous organ transplantation
- Concurrent or significant past (\>6 months) immuno-suppression
- Adult polycystic kidney disease
- Current use of an ESA
- On dialysis \*: patients can still be considered eligible after condition is reversed or treated
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00202345
Start Date
August 1 2004
End Date
February 1 2007
Last Update
May 5 2015
Active Locations (6)
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1
Central Coast Health
Gosford, New South Wales, Australia, 2250
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
3
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4006
4
Monash Medical Centre
Clayton, Victoria, Australia, 3168