Status:
COMPLETED
The Iron and Muscle Study
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
King's College London
University of Leicester
Conditions:
CKD Stage 3
CKD Stage 4
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This is a multi-center randomized controlled trial that will examine the efficacy of IV iron supplementation when compared to placebo, with and without exercise training, on changes in patient exercis...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Pregnancy or breast feeding (Female patients of childbearing 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
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04862715
Start Date
April 26 2019
End Date
February 21 2022
Last Update
March 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS