Reversal Of Arterial Disease by modulating Magnesium And Phosphate

Phase 4

Completed

• Conditions: calcification; vascular stiffness; 10013296; 10047066

• Registration Number: NL-OMON55005
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-09
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in PWV over 24 weeks between groups</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary<br /><br>- The difference in plasma T50 and CPP concentrations over 24 weeks<br /><br>- The difference in Mg, Phosphate, Klotho, FGF-23 and hsCRP concentrations over<br /><br>24 weeks<br /><br><br /><br>Explorative<br /><br>- In a subsample: the difference in 18F-FDG and 18F-NaF-PET scans over 24 weeks<br /><br>- Change in T50, CPP concentrations, FGF-23 and hsCRP 4 weeks after cessation<br /><br>of the intervention (T4). </p><br>