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

MiREnDa 2014.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: December 2012 to March 2018

  • Follow‐up period: 44 weeks

Participants
  • Setting: multicentre (3 sites)

  • Country: Germany

  • Relevant health status: CKD5D on HD

  • Number: treatment group (50); control group (47)

  • Mean age ± SD (years): treatment group (60.6 ± 11.3); control group (59.9 ± 13.4)

  • Sex (M/F); treatment group (40/10); control group (35/12)

  • Exclusion criteria: previous aldosterone antagonist treatment; history of hyperkalaemia and hypotension; pregnancy/lactation

Interventions Treatment group
  • Spironolactone 50 mg/day for 40 weeks


Control group
  • Placebo for 40 weeks

Outcomes
  • Death (any cause)

  • Hyperkalaemia: moderate hyperkalaemia (pre‐dialysis potassium levels of 6.0 to 6.5 mmol/L); severe hyperkalaemia (≥ 6.5 mmol/L)

  • LVM

  • EF

  • Residual kidney function: urine volume, mGFR

Identification
  • Authors name: Fabian Hammer

  • Institution: Department of Medicine I, Division of Cardiology, University Hospital Würzburg, Würzburg, Germany

  • Email: fabian.hammer@uni‐greifswald.de

  • Address: Department of Internal Medicine B, University Hospital Greifswald, Ferdinand‐Sauerbruch‐Street, 17475 Greifswald, Germany

Notes
  • Funding source: The MiREnDa trial was funded by the German Federal Ministry of Education and Research (01KG1202) and conducted under the auspices of the German Society of Nephrology. Additional funding was obtained from E.N.D.I.—the European Nephrology and Dialysis Institute

  • Complete follow‐up: treatment group (44/50, 88.0%); control group (41/47, 87.2%)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomly allocated 1:1 to either 50 mg spironolactone once daily or matching placebo using an algorithm for balanced randomised assignment for stratified randomizations."
Allocation concealment (selection bias) Low risk Quote: "patients were randomly allocated 1:1 to either 50 mg spironolactone once daily or matching placebo using an algorithm for balanced randomised assignment for stratified randomizations."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "MiREnDa was an investigator‐initiated, randomised, double‐blind, placebo‐ controlled trial to study the efficacy and safety of spironolactone in HD patients."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "MiREnDa was an investigator‐initiated, randomised, double‐blind, placebo‐ controlled trial"
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data balanced across intervention groups
Selective reporting (reporting bias) Low risk All prespecified outcomes have been reported in ClinicalTrials.gov identifier NCT01691053
Other bias Low risk The MiREnDa trial was funded by the German Federal Ministry of Education and Research (01KG1202) and conducted under the auspices of the German Society of Nephrology. Additional funding was obtained from E.N.D.I.—the European Nephrology and Dialysis Institute