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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

Cruzado 2015.

Methods
  • Study design: parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months

Participants
  • Country: Spain

  • Setting: multicentre

  • Inclusion criteria: kidney transplant recipients with persistent hyperparathyroidism > 6 months post transplant (eGFR > 30 mL/min, iPTH > 15 pmol/L, serum calcium > 2.63 mmol/L, and serum phosphate <1.2 mmol/L)

  • Number: treatment group (15); control group (15)

  • Mean age ± SD (years): treatment group (55.0 ± 13.6); control group (53.0 ± 11.8)

  • Sex (M/F): treatment group (7/8); control group (6/9)

  • Exclusion criteria: not reported

Interventions Treatment group
  • Cinacalcet (oral): 30mg daily (titrating up to 60 mg daily)


Control group
  • Subtotal parathyroidectomy


Co‐interventions
  • Not reported

Outcomes
  • Primary outcome: achievement of normocalcaemia

  • Level of iPTH, serum phosphate

  • Kidney function (eGFR)

  • BMD

  • Vascular calcification

  • Adverse events of medications

Notes
  • Funding source: Supported by Spanish Government Instituto de Salud Carlos III (ISCIII) Grants EC08/00237 and INT13/00126

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label study between medical and surgical treatments
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Insufficient information to permit judgement
Selective reporting (reporting bias) Low risk Reporting of all anticipated patient‐level outcomes including adverse events
Other bias Low risk Study appears free of other biases