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

Ito 2014.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 24 months

Participants
  • Setting: multicentre (12 sites)

  • Country: Japan

  • Relevant health status: CKD‐5D on PD; NYHA‐FC I and II

  • Number: treatment group (78); control group (80)

  • Mean age ± SD (years): treatment group (57.4 ± 12.3); control group (55.6 ± 14.4)

  • Sex (M/F); treatment group (55/23); control group (58/22)

  • Exclusion criteria: severe anaemia (Hb < 9.0 g/dL); NYHA‐FC III and IV heart failure; treatment with acid‐pH fluid dialysate; previous treatment with HD or transplantation within the preceding 3 years; pregnancy or suspected pregnancy

Interventions Treatment group
  • Spironolactone: 25 mg/day for 104 weeks


Control group
  • Standard care for 104 weeks

Outcomes
  • Death (any cause)

  • Death (cardiovascular)

  • Cardiovascular and cerebrovascular morbidity: acute MI

  • Hyperkalaemia: K > 6.0 mEq/L

  • Gynaecomastia

  • LVM

  • EF

Identification
  • Authors name: Yasuhiko Ito

  • Institution: Nephrology and Renal Replacement Therapy, Nagoya University, Nagoya, Japan

  • Email: yasuito@med.nagoya‐u.ac.jp

  • Address: 65 Tsurumai‐cho, Showaku, Nagoya 466‐8550, Japan

Notes
  • Funding source: This study was supported in part by a Grant‐in‐Aid for Progressive Renal Disease Research, Research on Rare and Intractable Diseases, from the Ministry of Health, Labor and Welfare of Japan

  • Complete follow‐up: treatment group (50/78, 64.1%); control group (58/80, 72.5%)

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 done
Allocation concealment (selection bias) Unclear risk Only states the study was randomised, does not ensure how sequence generation 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) Low risk All prespecified outcomes have been reported in The University Hospital Medical Information Network Clinical Trials Registry as UMIN000492
Other bias Low risk This study was supported in part by a Grant‐in‐Aid for Progressive Renal Disease Research, Research on Rare and Intractable Diseases, from the Ministry of Health, Labor and Welfare of Japan