The Iron and Muscle Study

Phase 1

• Conditions: Iron deficiency in stage 3-4 CKD; MedDRA version: 20.0 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: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-000144-25-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

• Patients with established CKD (Stages 3-4) not on dialysis
• Resting BP = 160/95mmHg
• Men and women aged 18 - 80 years
• Serum ferritin level less than 100µg/L AND/OR transferrin saturation =20%
• Haemoglobin 110 – 150 g/L
• Written informed consent

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Pregnancy or breast feeding (Female patients of child bearing age will be asked if there is any possibility they may be pregnant. This is standard of care and no pregnancy test will be requested unless there is doubt about this. IV iron is given to many pregnant patients in standard treatment and there is no evidence of harm to mother or foetus).
•Weight < 50kg
•Known allergy to iron therapy
•Haemochromatosis, porphyria cutanea tarda or history of acquired iron overload
•Intravenous iron within previous 6 weeks
•CRP > 50 mg/L
•Serum phosphate < 0.7 mmol/L.
•Active infection
•Current therapy with ESAs
•Uncontrolled atrial fibrillation
•Use of anticoagulants in those under consideration for muscle biopsy
•Unstable angina or heart attack within the last year
•Presence of solid organ cancer
•Known haemoglobinopathy, myelodysplasia, or myeloma
•Patients with peripheral vascular or musculoskeletal disease, who the investigator deems unable to carry out the 6MWT.
•Known severe aortic stenosis and pacemaker in-situ
•History of severe atopy
•Severe liver disease with serum transaminases > x3 upper limit of normal range according to local laboratory values.
•Severe lung disease with FEV1 known to be <50% predicted in last year
•Known heart failure with a left ventricular ejection fraction <45% in last year
•Any other health condition considered by the local Principal Investigator in which IV iron will be contraindicated.
•Insufficient understanding of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified