Iron deficiency anaemia associated with Chronic Kidney Disease MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: LLT Classification code 10066763 Term: Chronic iron deficiency anaemia System Organ Class: 10005329 - Blood an
Conditions
Interventions
Trade Name: Monofer
Product Name: Monofer
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: iron (III) isomaltoside 1000
CAS Number: 9004-66-4
Current Sponsor code: Iron olig
Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women aged =18 years; • Patients with stable CKD eGFR > 20 ml/min/1.73m2 • Resting BP = 160/95mmHg; • Able to give written and signed informed patient consent; • Able to complete study assessments; • Ferritin level less than 200µg/L OR transferrin saturation =20% and serum ferritin between 200-299µg/L; • Haemoglobin less than 150g/L; • Serum phosphate > 0.8 mmo/L; • A negative pregnancy test for females of child bearing potential; • For a female of child bearing potential must agree to acceptable birth control from screening through to Visit 8 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Age 500 ml) or surgery in the 30 days prior to recruitment; • Known allergy to iron therapy; • Haemochromatosis or history of acquired iron overload; • Parenteral iron therapy within the previous 6 weeks; • Inability to co-operate with study protocol; • CRP = 50 mg/L; • Active infection; • Symptomatic ischaemic heart disease; • 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 in last 6 weeks; • Patients with known haemoglobinopathy, myelodysplasia, myeloma; • Involvement in another CTIMP within the past four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Primary outcome time-point of evaluation: %change in iFGF23 from baseline to 1-2 days post infusion between two IMPs used. Co-primary endpoints: % change in iFGF23 from baseline to 2 weeks post-infusion; composite change in iFGF23 and delta change in phosphate at all time interventions.;Main Objective: To explore whether iron loading with third generation IV iron preparation differentially causes an increase in FGF23 and subsequent reduction in serum phosphate and this may impact markers of bone metabolism which may have longer term implications;Secondary Objective: 1: To test and explore the difference that may arise between the use of two different iron preparations in bone markers (1,25 Vitamin D, calcium, PTH, ALP, bone specific ALP and serum phosphate) and monitor the tolerance and safety of it (by monitoring events of hypophosphataemia) 2: To test and explore the difference that may arise between the use of two different iron preparations in haemoglobin response and ferritin levels 3: To test and explore the cardiac impact that may arise secondary to the difference in iFGF23 release caused by different iron preparations using cardiac biomarkers (troponin T and NT-pro BNP), pulse wave velocity measurements and ECG 4: To test and explore the impact that different iron preparations may have on this cohort of patients with regards to functional status via the use of accredited functionality scores such as the Fatigue Severity Scale and the Kidney Disease Quality of Life Instrument (KDQOL) ;Primary end point(s): The percentage change in iFGF23 from baseline to 1-2 days post-infusion between iron isomaltoside and ferric carboxymaltose. Percentage change in iFGF23 from baseline to 2 weeks post-infusion between iron isomaltoside and ferric carboxymaltose. Co-primary outcome: Composite of change in iFGF23 and delta change in phosphate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As per outcomes: Difference between the two treatments on bone markers (1,25 Vit D, calcium, PTH, ALP, bone specific ALP and serum phosphate levels) at each study visit and comparison to end. Difference in Pulse Wave Velocity Measurement between baseline and end-point Incidence of hypophosphataemia (<0.65 mmol/L) and severe hypophosphataemia (<0.3mmol/L) Markers of anaemia response (Hb, ferritin, TS%) at each study visit and comparison to end. Difference in functional status (KQDOL and Fatigue Severity Scale) between baseline, when performed and at end-point Effect on cardiac biomarkers (Troponin T and NT-proBNP) at each visit performed and in the case of troponin before and after infusion Effect on ECG: changes in PR interval, QRS duration, QTc, features of ischaemia on every visit performed. ;Timepoint(s) of evaluation of this end point: At each visit comparative analysis and to end point. Variables to be compared when performed with baseline measurement. In the case of troponin: at each visit and before and after infusion of iron. Comparative analysis and end-of-trial analysis for all parameters analysed between baseline and end and in-between iron preparatons. | — |
Countries
United Kingdom
Contacts
Public ContactProf Sunil Bhandari
Hull University Teaching Hospitals NHS Trust
Outcome results
None listed