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. 2014 Dec 9;2014(12):CD006254. doi: 10.1002/14651858.CD006254.pub2

Charytan 2005.

Methods

  • Study design: parallel RCT

  • Study duration: June 2002 and March 2003

  • Study follow‐up: 18 weeks
Participants

  • Country: USA and Canada

  • Setting: multicentre (16 centres)

  • Men and women, ≥ 18 years with CKD and SHPT but were not receiving dialysis; GFR of 15 to 50 mL/min/1.73 m²; one iPTH < 130 pg/mL; serum Ca ≥ 9.0 mg/dL

  • Number: treatment group (27); control group (27)

  • Mean age ± SD (years): treatment group (60.6 ± 15.6); control group (61.9 ± 15.1)

  • Sex (M/F): treatment group (16/11); control group (22/5)

  • Exclusion criteria: any unstable medical condition; pregnant or lactating; undergone parathyroidectomy or experienced MI in the previous 3 months; kidney transplantation at any time; changed vitamin D therapy in the previous 30 days; were likely to begin dialysis therapy or receive a kidney transplant within 18 weeks
Interventions Treatment group

  • Cinacalcet: 30 to 180 mg/d

  • Duration: 12 weeks titration, 6 weeks maintenance


Control group

  • Placebo: 30 to 180 mg/d

  • Duration: 12 weeks titration, 6 weeks maintenance


Co‐interventions

  • Treatment group: vitamin D (22%); phosphate binders (37%)

  • Control group: vitamin D (33%); phosphate binders (48%)
Outcomes

  • ≥ 30% reduction from baseline in mean iPTH

  • Percentage change in mean iPTH within each treatment group (efficacy)

  • Collection of adverse events and laboratory parameters (safety)
Notes

  • ITT: yes

  • Funding: "Supported in part by a grant from Amgen Inc. WL, PSK, and LCM are employees of Amgen Inc"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk NS
Allocation concealment (selection bias) Low risk Centralised interactive voice‐response system
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinded study
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NS
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up 30% of patients
Selective reporting (reporting bias) Low risk All the prespecified outcomes were reported
Other bias High risk Sponsor on authorship