Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Iron Sucrose in Stage 3/4 Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Melbourne Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00202345
First received: September 15, 2005
Last updated: March 8, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Kidney Failure
Anemia
Drug: Iron sucrose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: August 2004
Estimated Study Completion Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202345

Locations
Australia, New South Wales
Central Coast Health
Gosford, New South Wales, Australia, 2250
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4006
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6847
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Lawrence P McMahon, MD Melbourne Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00202345     History of Changes
Other Study ID Numbers: Iron Sucrose 61864
Study First Received: September 15, 2005
Last Updated: March 8, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:
Creatinine Clearance
Hemoglobin
Iron sucrose
Oral iron therapy
Ferritin
Transferrin saturation
Iron

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases
Ferric Compounds
Ferric oxide, saccharated
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014