patients with known chonic kidney disease with functional or absolute Iron deficiency Anaemia, and are greater than 18 years will be given repleacement iron therapy accoring to current local protocols and NICE guidelines MedDRA version: 15.0 Level: LLT Classification code 10022973 Term: Iron deficiency anaemias System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: COSMOFER
Product Name: COSMOFER
Pharmaceutical Form:
INN or Proposed INN: Iron III hydroxide dextran complex
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Co
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with established chronic kidney disease. (Stages III-V) (GFR using MDRD =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Pregnancy Age 40% Known allergy to iron therapy Haemochromatosis Parenteral iron therapy within the previous 6 weeks Inability to co-operate with study protocol Patients with potential confounding factors to NGAL measurement Patients who do not have renal failure (CKD stage I and II) Patients who are unable or do not wish to give consent. Patients being investigated for potential blood loss Patients with a haematological malignancy/ haemolysis Patients with known haemaglobinopathy Patients with a diagnosis of myeloma current smokers Any other contraindications to Monofer, Venofer or Cosmofer therapy listed on SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether three preparations of intravenous iron therapy affect markers of kidney injury including NGAL levels in serum and urine as a result of intravenous Iron therapy in patients with chronic kidney disease (CKD). The primary objective of this study is to: •To assess the effects of three preparations of intravenous (IV) iron in a cohort of CKD patients with biochemical functional or absolute iron deficiency (ferritin level less than 200 microg/l or/and transferrin saturation of <20%) on measures renal injury. •To determine whether iron isomaltoside, iron sucrose and iron dextran differ in their effects on markers of renal injury in comparison to baseline measures during the lead in period. •To determine whether IVI iron leads to potential transient AKI from assessment of changes in markers of renal injury from baseline markers prior to iron administration. To determine for iron isomaltoside if there is a difference related to dose of drug (low dose and normal dose);Secondary Objective: Secondary objectives are to determine •The effect (efficacy) of iron supplementation on haematinic profiles and haemoglobin levels. •Incidence of significant side affects •Whether hepcidin measurements are a reliable estimate of iron repletion and deficiency in CKD •Change in urinary protein excretion •Change in patients’ Quality of Life (Measured using the SF-36v2™ questionnaire) •NHS health care resources used;Primary end point(s): The primary outcome variable of this study is the time course of markers of renal injury, their quantification and relationship to proteinuria and renal function and NGAL. Correlation curves will be drawn of serum creatinine/eGFR versus NGAL measurements (serum and urinary), and oxidative stress markers and NGAL and renal dysfunction. Patients will be grouped according to injury status at 24 hours as assessed by NGAL and oxidative stress measurements. Examination of the association between NGAL measurement and AKI status based | — |
Countries
United Kingdom
Outcome results
None listed