Iron-deficiency in anaemia of end stage renal disease. MedDRA version: 16.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 100000004857 MedDRA version: 16.0 Level: LLT Classification code 10066763 Term: Chronic iron deficiency anaemia System Organ Class: 100000004851 MedDRA ver
Conditions
Interventions
Trade Name: Venofer
Product Name: Iron sucrose (Venofer)
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Iron sucrose
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients > or = 18 years - Patients established on a chronic haemodialysis programme for end-stage renal failure - Clinically stable (Principal Investigator’s judgement) -Within 0–12 months since commencing haemodialysis -Ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 2080
Exclusion criteria
Exclusion criteria: - Life expectancy 50 mg/L - Active infection - Current active malignancy (with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia) - Known HIV or active hepatitis B or C - Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range - Advanced heart failure (NYHA IV) - Pregnancy or breast feeding - History of acquired iron overload - Previous severe hypersensitivity reactions to IV iron sucrose (Venofer®) - Subject has any kind of disorder that compromises their ability to give written informed consent and/or to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients.; Secondary Objective: To determine whether a regimen of proactive IV iron supplementation in haemodialysis patients reduces mortality / cardiovascular endpoints compared to a reactive low-dose regimen. To compare the effect of the two regimens on ESA dose requirements, RBC transfusions, complications of haemodialysis treatment, and QoL. ;Primary end point(s): Time to all-cause death or a composite of non-fatal cardiovascular events (myocardial infarction, stroke, and hospitalisation for heart failure) adjudicated by a blinded Endpoint Adjudication Committee.; Timepoint(s) of evaluation of this end point: This is an event-driven trial - the evaluation will only be conducted once the required number of events are accrued (approximately 2-3 years). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SECONDARY EFFICACY - Incidence of all-cause death and a composite of myocardial infarction, stroke, and hospitalisation for heart failure as recurrent events. - Time to (and incidence of) all-cause death - Time to (and incidence of) composite cardiovascular event - Time to (and incidence of) myocardial infarction - Time to (and incidence of) stroke - Time to (and incidence of) hospitalisation for heart failure - ESA dose requirements - Transfusion requirements - EQ-5D QOL and KDQOL SECONDARY SAFETY - Vascular access thrombosis - All-cause hospitalisation - Hospitalisation for infection - Infection episodes ; Timepoint(s) of evaluation of this end point: This is an event-driven trial - the evaluation will only be conducted once the required number of events are accrued (approximately 2-3 years). | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Iain Macdougall
King's College Hospital NHS Foundation Trust
Outcome results
None listed