Iron Sucrose in Stage 3/4 Kidney Disease

NCT00202345 | Completed Phase 3

• 1 other identifier: Iron Sucrose 61864
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Kidney Failure; Anemia

Keywords

Creatinine Clearance; Hemoglobin; Iron sucrose; Oral iron therapy; Ferritin; Transferrin saturation; Iron

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Iron sucrose DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (6)

Central Coast Health

Gosford, New South Wales, 2250, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4006, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

The Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6847, Australia

Location

MeSH Terms

Conditions

Renal Insufficiency; Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Lawrence P McMahon, MD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2004
• Study Completion: February 1, 2007
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

AU (6)