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

Lindberg 2003.

Methods

  • Study design: parallel RCT

  • Study duration: NS

  • Study follow‐up: 18 weeks
Participants

  • Country: USA, Canada

  • Setting: multicentre (23 centres)

  • Patients ≥ 18 years, treated for at least 3 mo with HD; PTH levels ≥ 300 pg/mL despite receiving standard of care (phosphate binders and/or vitamin D sterols); serum calcium corrected for serum albumin ≥ 8.8 mg/dL and < 11.0 mg/dL; serum phosphorous ≥ 2.5 mg/dL; Ca x P < 70 mg²/dL². Patients receiving vitamin D sterols were required to be on a stable dose for at least 21 days before enrolment; dialysate calcium concentration and calcium supplements/oral phosphate binders dose could not be changed during the 7 days before enrolment

  • Number: treatment group (39); control group (39)

  • Mean age ± SD (years): treatment group (52.7 ± 16.4); control group (48.8 ± 15.6)

  • Sex (M/F): treatment group (24/15); control group (22/17)

  • Exclusion criteria: medically unstable; evidence of an active infectious or malignant process or diseases known to cause hypercalcaemia; Hb concentration < 9.0 g/dL or a HCT < 27%; liver transaminases and bilirubin levels more than twice the upper limit of normal
Interventions Treatment group

  • AMG‐073: 10 to 50 mg/d

  • Duration: 12 weeks titration, 6 weeks maintenance


Control group

  • Placebo


Co‐interventions

  • Treatment group: vitamin D (67%); phosphate binders (87%)

  • Control group: vitamin D (62%); phosphate binders (87%)
Outcomes

  • Reduction in PTH ≥ 30% during the maintenance phase

  • Mean percent change from baseline for PTH, serum calcium, phosphorous, and Ca x P during the maintenance phase

  • Adverse events

  • Laboratory variables (haematology and biochemistry)

  • Vital signs
Notes

  • ITT: no

  • Funding: "Funding for this study was provided by Amgen 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 Low risk Double‐blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk NS
Incomplete outcome data (attrition bias) 
 All outcomes High risk Loss to follow‐up 14.1% of patients
Selective reporting (reporting bias) High risk Not reported systematically (end of treatment calcium, phosphorous, PTH and adverse events)
Other bias High risk Sponsor on authorship