Chronic Kidney Disease stages 3b to 5 with iron deficiency
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer 100mg/ml
Pharmaceutical Form: Solution for infusion in administration system
INN or Proposed INN: iron(iii)isomaltoside 1000
Concentration unit: mg/ml millig
Sponsors
Hull and east Yorkshire Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage of CKD will be calculated by the 4 point MDRD equation. Patients must have a stable eGFR, as defined by =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Pregnancy or breast feeding (To avoid pregnancy, women have to be postmenopausal, (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended: Contraceptive pills, intrauterine devices (IUD) contraceptive depot injections (prolonged release gestagen), subdermal implantation, vaginal ring and transdermal patches. Age 50 mg/L Active infection Symptomatic ischaemic heart disease Current therapy with ESA agents Patients with atrial fibrillation Patients with potential confounding factors - cancer, (with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia) Patients who are unable or do not wish to give consent. Patients being investigated for potential blood loss Patients who have received blood transfusions Patients with known haemoglobinopathy, myelodysplasia, myeloma, Patients with musculoskeletal disease, who the investigator deems unable to carry out the 6MWT. Patients who have been involved in another medicinal trial (CTIMP) within the past four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether IV iron supplementation in iron deficient non-anaemic CKD patients improves physical and functional status assessed by the 6MWT and questionnaires (KDQoL and MLHF).;Secondary Objective: Improvement in cardiac structure and function. Monitoring of physiological aspects using pulse oximetry and cardiac harness for heart and respiratory rate. Change in New York Heart association functional classification (NYHA) To investigate cardiac iron loading based on MRI using T2* in a small cohort of patients in a single centre (10 patients) To observe improvement in renal function as assessed with eGFR;Primary end point(s): To compare the effect of IV iron versus placebo on changes in physical function based on a 6-minute walk test and qualitative questionnaires in iron deficient non-anaemic chronic kidney disease patients.;Timepoint(s) of evaluation of this end point: Difference in the co analysis of a 6-minute walk test and questionnaires (KDQoL and Minnesota Living and Heart Failure Questionnaire (MLHF) patient quality of life and wellbeing) between experimental and placebo groups (Group 1) and control groups (Groups 2 and 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Speckle tracking Echo parameters of cardiac function after 6MWT Hospitalisation rates from any cause in each group will be noted All-cause death and a composite of non-fatal myocardial infarction, stroke, and hospitalisation for heart failure All-cause mortality will be recorded Cardiovascular events, stroke, non-fatal myocardial infarction will be recorded Change in New York Heart association functional classification (NYHA) Thrombotic episodes Restless leg syndrome questionnaire ;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Sunil Bhandari
Hull and East Yorkshire Hospitals Trust
Outcome results
None listed