{
  "abstract": "Rationale & Objective: Fluid overload is a major cause of treatment failure in patients receiving peritoneal dialysis (PD), and insufficient sodium removal is involved with this condition. This study evaluated the efficacy and safety of a novel low-sodium (LS) PD solution (Na 126 mmol/L, glucose 1.6%) combined with standard-sodium (SS) PD solutions as a new approach to enhance sodium removal. Study Design & Participants: In this multicenter, double-blind, randomized, parallel-group study, outpatient PD patients at 20 facilities in Japan were randomly assigned (2:1) to the LS PD solution group or the SS PD solution group (Na 135 mmol/L, glucose 1.35%). Exposure: The test solution replaced 1 daily exchange and was combined with at least 1 standard PD solution. Patients who met dose-escalation criteria at week 4 switched to twice-daily dosing. Outcomes: The primary outcome was the change in daily peritoneal sodium removal from baseline to week 8. Secondary outcomes included peritoneal sodium removal per bag exchange, total daily (peritoneal and urinary) sodium, water removal, and dialysis adequacy. Analytical Approach: Efficacy, including sodium removal in PD treatment, was analyzed in the full analysis set; safety was assessed in all patients. Results: The mean change in daily peritoneal sodium removal was significantly higher in the LS PD solution group (n = 51, 28.7 ± 36.2 mmol/d) than in the SS PD solution group (n = 27, -6.3 ± 26.2 mmol/d; P < 0.001). Other outcomes showed no significant differences. Drug-related adverse events (mainly hyponatremia) were observed in the LS PD solution group; however, they were generally mild and completely reversible. Limitations: Participants with relatively preserved residual kidney function and incremental PD were overrepresented. Conclusions: The LS PD solution, when combined with standard PD solutions, increased sodium removal without compromising dialysis adequacy or residual kidney function. Plain-Language Summary: Fluid overload is common in patients receiving peritoneal dialysis, a home-based therapy for kidney failure. It is closely linked to excess sodium and can lead to hypertension, cardiovascular complications, and discontinuation of dialysis. Although sodium restriction is the standard approach, changing dietary habits is difficult for many patients. To address this issue, we developed a low-sodium dialysis solution to enhance sodium removal. Patients used this solution once or twice daily in place of standard fluids. The results showed increased sodium removal without adverse effects. This simple modification may improve fluid control and support better long-term management in peritoneal dialysis patients.",
  "abstract_shown": true,
  "affiliations": [
    "Division of Research Control, St Luke’s International University, Tokyo, Japan",
    "R&D Division, Terumo Corporation, Kanagawa, Japan",
    "Clinical Development Department, Terumo Corporation, Tokyo, Japan",
    "Department of Nephrology and Rheumatology, Aichi Medical University, Nagakute, Aichi, Japan",
    "Department of General Internal Medicine, Saitama Medical University, Saitama, Japan"
  ],
  "article_type": "research article",
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  "author_total": 6,
  "authors": [
    {
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        0
      ],
      "name": "Masaaki Nakayama"
    },
    {
      "affs": [
        1
      ],
      "name": "Hiroaki Takahashi"
    },
    {
      "affs": [
        1
      ],
      "name": "Hideka Hosaka"
    },
    {
      "affs": [
        2
      ],
      "name": "Fumiyo Uosaki"
    },
    {
      "affs": [
        3
      ],
      "name": "Yasuhiko Ito"
    },
    {
      "affs": [
        4
      ],
      "name": "Hidetomo Nakamoto"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/16mw2ywex62wp.bib",
  "cited_by": 0,
  "doi": "10.1016/j.xkme.2026.101487",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2590059526002499",
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  "issns": [
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  "landing_url": "https://doi.org/10.1016/j.xkme.2026.101487",
  "language": "en",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
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  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
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    ],
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      "lcc",
      "RC870-923"
    ],
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      "openalex",
      "2727|Dialysis and Renal Disease Management"
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  "openalex": "W7201874052",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13717097/pdf/?tool=EBI",
  "pmcid": "PMC13717097",
  "pmid": "42959528",
  "published": "2026-08-07",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/16mw2ywex62wp.ris",
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  "subjects": [
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      "field": "medicine",
      "origin": "openalex:2727|Dialysis and Renal Disease Management",
      "subfield": "general"
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  ],
  "title": "Low-Sodium Peritoneal Dialysis Solution (Na 126 mmol/L) for Enhanced Sodium Removal: A Multicenter Randomized Controlled Trial",
  "title_text": "Low-Sodium Peritoneal Dialysis Solution (Na 126 mmol/L) for Enhanced Sodium Removal: A Multicenter Randomized Controlled Trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-02T12:21:29Z",
  "url": "https://research.draconitic.com/paper/16mw2ywex62wp",
  "venue": "Kidney Medicine",
  "versions": []
}