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

Trillini 2015.

Methods

  • Study design: open‐label, cross‐over RCT

  • Duration of study: not reported

  • Duration of follow‐up: 6 months
Participants

  • Country: Italy

  • Setting: single centre

  • Inclusion criteria: kidney transplant recipients > 18 years; iPTH > 80 pg/mL; serum calcium ≤ 2.55 mmol/L; SCr < 177 µmol/L; maintenance immunosuppressive therapy with CNI and MMF or azathioprine; no ongoing vitamin D analogues, and no evidence of active hepatitis C or B virus or HIV infection or drug or alcohol abuse

  • Number: treatment group (22); control group (21)

  • Mean age ± SD (years): treatment group (53.4 ± 8.7); control group (51.2 ± 9.8)

  • Sex (M/F): treatment group (17/5); control group (13/8)

  • Exclusion criteria: hypersensitivity or intolerance to paricalcitol; > 30% change in SCr or acute rejection episodes over the past 6 months; chronic clinical conditions expected to affect completion of the study or jeopardise data interpretation; pregnant or lactating or fertile women without adequate contraception
Interventions Treatment group

  • Paricalcitol (oral): 1 µg/d, titrated up to 2 µg/d if tolerated (calcium ≤ 2.55 mmol/L, phosphate ≤ 1.65 mmol/L and iPTH < 50 pg/mL)


Control group

  • No treatment


Co‐interventions

  • Not reported
Outcomes

  • Change in BMD at lumbar spine

  • Change in serum iPTH, serum calcium, phosphate

  • Biomarkers of bone turnover

  • Adverse events of medication
Notes

  • Funding source: Abbvie (supplied paricalcitol; unconditional grant)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated randomisation list
Allocation concealment (selection bias) Unclear risk Randomised to two treatments by an independent investigator at the coordinating centre. Not sufficient detail to perform adjudication
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Allocated to two different treatments (oral drug versus no treatment)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 2/43 patients did not complete study (intervention group)
Selective reporting (reporting bias) Low risk Patient‐centred outcomes systematically captured and reported
Other bias Low risk No additional threats to validity identified