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Clinical Trial Details

Trial ID: L1751
Source ID: NCT04862715
Associated Drug: Ferinject
Title: The Iron and Muscle Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: CKD Stage 3|CKD Stage 4|Iron-deficiency
Interventions: DRUG: Ferinject|OTHER: Placebo: NaCl (sodium chloride 0.9%)
Outcome Measures: Primary: Exercise capacity as measured by 6 minute walk distance (6MWD), An exercise capacity test, 4 weeks | Secondary: Haemoglobin levels, Haemoglobin, 12 weeks|Iron status, Ferritin, 12 weeks|Renal function, urea,, 12 weeks|VO2 peak test (in a sub-set of participants), To assess physical capacity, 12 weeks|Isokinetic dynamometry (muscle strength), To assess physical capacity, 12 weeks|Functional capacity, sit-to-stand 60 to assess lower limb function, 12 weeks|KDQOL-36, To assess quality of life by classifying patient general state of health. 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor., 12 weeks|Skeletal muscle phosphocreatine recovery halftime (PCr t1/2) on MRI spectroscopy (n=40 patients at baseline and 4 weeks), To assess skeletal muscle metabolism, 12 weeks|The Work and Social Adjustment Scale (WSAS), To assess quality of life by classifying out more about how participant fatigue impacts on their daily life 0 - Not at all, 1 to 2 - Slightly, 3 to 4 - Definitely, 5 to 6 - markedly and 7 to 8 - Very severely impaired /Cannot work, 12 weeks|To assess the impact of iron regulatory genes e.g. HFE, TMPRSS6 etc. on the primary and secondary endpoints of the study (exploratory only), Patients will be asked if they are willing to provide DNA from a single sample of whole blood to facilitate analysis of up to 90 iron regulatory genes, including HFE and TMPRSS. Iron regulatory gene expression measured by qPCR e.g. Hepcidin, Hemojuvelin, Ferroportin, Trf1 receptor, and iron regulatory proteins-1 \& -2., 12 Weeks|Iron Status, TSAT, 12 weeks|Renal Function, creatinine, 12 weeks|Renal Function, estimated glomerular filtration rate to be used to determine renal function, 12 weeks
Sponsor/Collaborators: Sponsor: King's College Hospital NHS Trust | Collaborators: King's College London|University of Leicester
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 75
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-04-26
Completion Date: 2022-02-21
Results First Posted:
Last Update Posted: 2022-03-02
Locations: King's College Hospital NHS Foundation Trust, London, SE5 9RS, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04862715