Funded in part by Mitsubishi Tanabe Pharma Corporation
A Randomized Trial of Magnesium Oxide and Oral Carbon Adsorbent for Coronary Artery Calcification in Predialysis CKD
Sakaguchi Y, Hamano T, Obi Y, Monden C, Oka T, Yamaguchi S, Matsui I, Hashimoto N, Matsumoto A, Shimada K, Takabatake Y, Takahashi A, Kaimori JY, Moriyama T, Yamamoto R, Horio M, Yamamoto K, Sugimoto K, Rakugi H, Isaka Y
Journal of the American Society of Nephrology : JASN · 111 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Nonprofit
- American Society of Nephrology
- Company
- Mitsubishi Tanabe Pharma Corporation
Based on 2 listed funder(s).
Publication
- Published
- 2019-04-29 · J Am Soc Nephrol · vol. 30 · issue 6 · pp. 1073–1085
- Publisher
- American Society of Nephrology
- Cited
- 153 citations · more than 99% of similar papers · 11.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 66 works
- Access
- Open access (repository copy)
- Research areas
- Parathyroid Disorders and Treatments · Magnesium in Health and Disease · Dialysis and Renal Disease Management
- Keywords
- Medicine, Internal medicine, Randomized controlled trial, Kidney disease, Diabetes mellitus, Coronary artery disease, Gastroenterology, Endocrinology
- MeSH
- humans, disease progression, oxides, carbon, magnesium oxide, prognosis, treatment outcome, administration, oral, severity of illness index, patient compliance, comorbidity, primary prevention, reference values, aged, middle aged, hospitals, university, female, male, renal insufficiency, chronic, coronary artery disease, vascular calcification
20 authors
From US, JP
- Yusuke Sakaguchi
- Takayuki Hamano · corresponding
- Yoshitsugu ObiUniversity of California, Irvine
- Chikako MondenOsaka Kaisei Hospital
- Tatsufumi OkaPediatric Nephrology of Alabama
- Satoshi YamaguchiPediatric Nephrology of Alabama
Abstract
Background
Developing strategies for managing coronary artery calcification (CAC) in patients with CKD is an important clinical challenge. Experimental studies have demonstrated that magnesium inhibits vascular calcification, whereas the uremic toxin indoxyl sulfate aggravates it.
Methods
To assess the efficacy of magnesium oxide (MgO) and/or the oral carbon adsorbent AST-120 for slowing CAC progression in CKD, we conducted a 2-year, open-label, randomized, controlled trial, enrolling patients with stage 3-4 CKD with risk factors for CAC (diabetes mellitus, history of cardiovascular disease, high LDL cholesterol, or smoking). Using a two-by-two factorial design, we randomly assigned patients to an MgO group or a control group, and to an AST-120 group or a control group. The primary outcome was percentage change in CAC score.
Results
We terminated the study prematurely after an interim analysis with the first 125 enrolled patients (of whom 96 completed the study) showed that the median change in CAC score was significantly smaller for MgO versus control (11.3% versus 39.5%). The proportion of patients with an annualized percentage change in CAC score of ≥15% was also significantly lower for MgO compared with control (23.9% versus 62.0%). However, MgO did not suppress the progression of thoracic aorta calcification. The MgO group's dropout rate was higher than that of the control group (27% versus 17%), primarily due to diarrhea. The percentage change in CAC score did not differ significantly between the AST-120 and control groups.
Conclusions
MgO, but not AST-120, appears to be effective in slowing CAC progression. Larger-scale trials are warranted to confirm these findings.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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