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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00202345 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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Iron Sucrose in Stage 3/4 Kidney Disease
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Scientific title:
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Assessment of the Use of Intravenous Iron Sucrose to Maintain Haemoglobin Levels and Delay the Onset of Use of Erythropoietic Agents and/or Dialysis in Stage 3/4 Chronic Kidney Disease |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00202345 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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Lawrence P McMahon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Melbourne Health |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Kidney Failure
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Intervention(s)
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Drug: Iron sucrose
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Primary Outcome(s)
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The primary endpoint will be the change in Hb concentration at 12 months or termination (dialysis, commencement of an ESA). Minimum permitted enrolment is 6 months.
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Secondary Outcome(s)
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The secondary endpoints will be the change in renal function (calculated creatinine clearance), the quality of life, the time taken to dialysis, the time from randomization to the requirement of an ESA and the number of hospitalization days.
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Secondary ID(s)
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Iron Sucrose 61864
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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