calcification vascular stiffness
Conditions
Interventions
This study has 4 intervention arms:
A) Magnesium citrate
B) Magnesium Placebo
C) Magnesium citrate + sucroferric oxyhydroxide
D) Magnesium Placebo + sucroferric oxyhydroxide
Concluding: a doubble b
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged between 18-80 years and a life expectancy >1 year - CKD patient with an eGFR 15-50 ml/min/1.73m2 - Plasma magnesium concentration 0.5-1.4 mmol/L - Plasma phosphate concentration 0.8-1.6 mmol/L - Provide informed consent
Exclusion criteria
Exclusion criteria: - Any phosphate binding therapy (with exception of calcium carbonate) - Unwilling to discontinue over-the-counter magnesium supplementation (for the study duration) - Renal transplantation in medical history or expected transplantation within 6 months - Prolongation of QTc interval of > 500 ms, 2nd or 3rd degree atrio-ventricular block on ECG or bradycardia (heart rate below 50 bpm on screenings ECG) - Atrial fibrillation or atrial flutter at last clinical or screenings ECG - Known unstable carotid plaques - Endoprothesis of the aorta - Hemochromatosis or other causes of iron overload, or hemoglobin > 10.5 mmol/L - Chronic diarrhea or gastrointestinal absorption disorders (ao gastric bypass surgery, partial resection of the small-intestines, Crohn disease etc). - Chronic use of antibiotics - Active malignancy - Pregnancy or lactation - Serious substance abuse - Recurrent incompliance for medication intake or hospital visits, i.e. *no- shows* - No sufficient understanding of the Dutch or English language - Inability to measure PWV or to take blood samples for any reason, inability to swallow medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in PWV over 24 weeks between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary - The difference in plasma T50 and CPP concentrations over 24 weeks - The difference in Mg, Phosphate, Klotho, FGF-23 and hsCRP concentrations over 24 weeks Explorative - In a subsample: the difference in 18F-FDG and 18F-NaF-PET scans over 24 weeks - Change in T50, CPP concentrations, FGF-23 and hsCRP 4 weeks after cessation of the intervention (T4). | — |
Countries
Netherlands
Outcome results
None listed