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

IMPACT SHPT Study 2012.

Methods

  • Study design: parallel, open‐label RCT

  • Study duration: NS

  • Study follow‐up: 28 weeks
Participants

  • Country: multinational

  • Setting: multicentre (89 centres)

  • Eligible patients were aged ≥ 8 years with Stage 5 CKD receiving maintenance HD 3 times/wk for at least 3 months before screening and were to continue HD during the study; serum iPTH 130 to 700 pg/mL; total alkaline phosphatase ≥ 0 U/L; calcium ≤ 10.0 mg/dL; Ca x P ≤ 5 mg²/dL² for US centres or ≤ 70 mg²/dL² for non‐US centres; iPTH 300–800 pg/mL; calcium 8.4 to 10.0 mg/ dL; phosphorous ≤ 6.5 mg/dL

  • Number: treatment group (134); control group (134)

  • Mean age ± SD (years): treatment group‐IV (59.9 ± 12.0); treatment group‐oral (65.1 ± 12.5); control group‐IV (61.2 ± 12.7); control group‐oral (65.7 ± 13.5)

  • Sex (M/F): treatment group‐IV (38/26); treatment group‐oral (43/27); control group‐IV (38/26); oral group‐oral (49/23)

  • Exclusion criteria: allergic reaction or significant sensitivity to any study drug; expected daily requirement of > 2.0 g of oral elemental calcium; previous parathyroidectomy; chronic gastrointestinal disorders; clinically significant liver disease and use of known inhibitors or inducers of cytochrome P450 3A or of drugs metabolized by cytochrome P450 2D6 within 2 weeks before study drug administration
Interventions Treatment group

  • Cinacalcet

  • Low dose vitamin D

  • Duration: 28 weeks


Control group

  • Vitamin D


Co‐interventions: NS
Outcomes

  • Mean iPTH value of 150 to 300 pg/mL during weeks 21 to 28

  • Achieved ≥ 30% or ≥ 50% reduction from baseline in iPTH

  • Hypocalcaemia (mean calcium < 8.4 mg/dL) during weeks 21 to 28

  • Hypercalcaemia (mean calcium > 10.5 mg/dL) during weeks 21 to 28

  • BSAP

  • Alkaline phosphatase
Notes

  • ITT: yes

  • Funding: "The IMPACT SHPT study was funded by Abbott Laboratories Inc. Writing and editorial assistance, funded by Abbott Laboratories Inc., was provided by Roland Tacke, PhD, Marsha Hall and Colleen Hedge of Scientific Connexions, Newtown, PA, USA"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Generated by Clinical Statistics department of Abbott
Allocation concealment (selection bias) Low risk Interactive voice‐response system
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not 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 24.3% of patients
Selective reporting (reporting bias) Low risk All the prespecified outcomes were reported
Other bias High risk Sponsor on authorship; sponsor involved in writing manuscript; sponsor held data and analysed data