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

Evenepoel 2014.

Methods

  • Study design: double‐blind, placebo‐controlled RCT

  • Duration of study: not reported

  • Duration of follow‐up: 52 weeks
Participants

  • Country: Belgium, Norway, Italy, France, Denmark, Poland, USA, Switzerland

  • Setting: multicentre

  • Inclusion criteria: kidney transplant recipient ≥18 years of age (between 9 weeks and 24 months post transplant) with stable kidney function (eGFR ≥ 30 mL/min/1.73 min2), serum calcium >2.63 mmol/L, and iPTH >100 pg/mL

  • Number: treatment group (57); control group (57)

  • Mean age ± SD (years): treatment group (53.0 ± 10.7); control group (51.7 ± 9.9)

  • Sex (M/F): treatment group (31/26); control group (32/25)

  • Exclusion criteria: not reported
Interventions Treatment group

  • Cinacalcet (oral): 30 mg daily titrated every 4 weeks to maximum 180 mg/d based on iPTH level


Control group

  • Placebo


Co‐interventions

  • Not reported
Outcomes

  • Achievement of serum calcium < 2.55 mmol/L

  • BMD at femoral neck, lumbar spine, distal radius

  • Serum calcium, phosphate, iPTH, FGF‐23

  • Biomarkers of bone turnover

  • Kidney function (eGFR) and urinary calcium

  • Adverse events of medications
Notes

  • Funding source: " This study was funded by Amgen Inc. K Cooper, H Deng and S Yue are employees and stockholders of Amgen Inc. P Evenepoel has been a member of advisory boards, received grant support and speaker’s fees from Amgen."

  • Trial registration: not reported (Amgen protocol 20062007)
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 Low risk Double‐blinded placebo‐controlled trial
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 10/114 discontinued study with equal attrition in both groups
Selective reporting (reporting bias) Low risk Patient‐level outcomes reported as expected
Other bias High risk Funded by Amgen; 3 authors are employees of Amgen