ACHIEVE Study 2008.

Methods	Study design: parallel, open‐label RCT Study duration: NS Study follow‐up: 27 weeks
Participants	Country: USA Setting: multicentre (42 centres) Patients ≥ 18 years; received HD for ≥ 3 mo; were receiving either paricalcitol or doxercalciferol to manage SHPT; historical plasma PTH values between 150 and 800 pg/mL (confirmed during screening); albumin‐corrected serum total calcium concentrations ≥ 8.4 mg/dL. Patients with PTH levels between 300 to 800 pg/mL were considered without regard to serum Ca x P levels, whereas those with PTH levels between 150 to 300 pg/mL were considered only if Ca x P > 55 mg²/dL². After a 3‐wk washout period during which vitamin D therapy was withheld, PTH and calcium levels were measured again on at least 2 occasions. Patients with mean PTH values > 300 pg/mL and mean calcium levels ≥ 8.4 mg/dL qualified for study Number: treatment group (87); control group (86) Mean age ± SD (years): treatment group (57.7 ± SD 14.9); control group (59 ± 12.4) Sex (M/F): treatment group (52/35); control group (45/41) Exclusion criteria: pregnant or nursing; undergone a parathyroidectomy within the previous 3 mo; involved in any other clinical study within the past 30 d; had received cinacalcet previously
Interventions	Treatment group Cinacalcet Low dose vitamin D Duration: 16 weeks titration, 11 weeks maintenance Control group Vitamin D Co‐interventions: NS
Outcomes	Simultaneously achieved a mean PTH between 150 and 300 pg/mL and a mean Ca x P value < 55 mg²/dL² Achieved KDOQI targets for PTH, calcium, phosphorous, and Ca x P individually Absolute and percentage change from baseline in values for PTH, calcium, phosphorous, and Ca x P Proportion with 30% reduction in PTH
Notes	ITT: yes Funding: "The ACHIEVE study (Study ID Number 20050102) and the preparation of this manuscript were funded by Amgen, Inc. The authors wish to thank Nelson Erlick, DPM, MS, on behalf of Amgen Inc. and Jane Mannion, MS, Amgen Inc. for their assistance in the preparation of this manuscript (Ms Mannion is currently employed by Baxter International, Inc.)"
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	NS
Allocation concealment (selection bias)	Unclear risk	NS
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not used
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not used
Incomplete outcome data (attrition bias) All outcomes	High risk	Lost to follow‐up 24% of the patients
Selective reporting (reporting bias)	Low risk	Data available for all included outcomes
Other bias	High risk	Sponsor on authorship