NL-OMON55005
Completed
Phase 4
Reversal Of Arterial Disease by modulating Magnesium And Phosphate - ROADMAP trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- calcification
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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
- •\- 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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