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. 2021 Feb 15;2021(2):CD013109. doi: 10.1002/14651858.CD013109.pub2

Matsumoto 2014.

Study characteristics
Methods

  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 3 years
Participants

  • Setting: multicentre (5 sites)

  • Country: Japan

  • Relevant health status: CKD‐5D on HD; 24‐hour urinary output of < 500 mL

  • Number: treatment group (157); control group (152)

  • Mean age ± SD (years): treatment group (67.4 ± 12.3); control group (66.7 ± 11.2)

  • Sex (M/F); treatment group (113/157); control group (90/152)

  • Other relevant information:

  • Exclusion criteria: history of non‐compliance (including noncompliance with HD); unstable vascular access, hypotension, hepatic failure, active malignancy, or any life‐threatening disease other than ESKD
Interventions Treatment group

  • Spironolactone: 25 mg/day for 156 weeks


Control group

  • Standard care for 156 weeks
Outcomes

  • Death (any cause)

  • Death (cardiovascular)

  • Hyperkalaemia: life‐threatening hyperkalaemia (serum potassium level > 6.8 mEq/L)

  • Gynaecomastia
Identification

  • Authors name: Matsumoto Y, MD

  • Institution: Department of Nephrology and Dialysis, Shizuoka City Hospital, Shizuoka, Japan

  • Email: matsumoto16@aol.com

  • Address: 10‐93 Ohtemachi, Aoi‐ku, Shizuoka 420‐8630, Japan
Notes

  • Funding source: not reported

  • Complete follow‐up: treatment group (112/157, 71.3%); control group (128/152, 84.2%)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only states the study was randomised, does not ensure how sequence generation was done
Allocation concealment (selection bias) Unclear risk Only states the study was randomised, does not ensure how sequence generation was done
Blinding of participants and personnel (performance bias)
All outcomes High risk "Open‐label" study
Blinding of outcome assessment (detection bias)
All outcomes High risk "Open‐label" study
Incomplete outcome data (attrition bias)
All outcomes High risk Imbalance in numbers for missing data across intervention groups
Selective reporting (reporting bias) Unclear risk Protocol: not reported
Other bias Unclear risk Funding: not reported