| Methods |
Study design: open‐label, placebo‐controlled, parallel RCT Duration of study: January 2013 to February 2014 Duration of follow‐up: 44 weeks |
| Participants |
Country: Norway Setting: single centre Inclusion criteria: aged ≥ 18 years; received a kidney transplant or a combined kidney‐pancreas transplant; CNI treatment, eGFR > 30 mL/min, plasma calcium 2.0 to 2.6 mmol/L Number: treatment group (37); control group (40) Mean age ± SD (years): treatment group (55.6 ± 13.3); control group (55.1 ± 12.6) Sex (M/F): treatment group (27/10); control group (34/6) Exclusion criteria: previous total parathyroidectomy; ongoing (or immediate intent to embark on) treatment with vitamin D, VDRA or calcimimetic drugs; severe osteoporosis in the axial skeleton; history of allergic reactions or significant sensitivity to paricalcitol or similar drugs; ongoing pregnancy; donor age > 75 years |
| Interventions |
Treatment group
Control group
Co‐interventions
|
| Outcomes |
ACR Gene expression profiles Histopathology (inflammation or fibrosis) Proteinuria Plasma PTH SCr C‐reactive protein, low‐density lipoprotein cholesterol, alkaline phosphatase, calcium, phosphate Endothelial function Measured GFR (iohexol) Serum 25‐hydroxy vitamin D |
| Notes |
Funding source: PhD grant from South Eastern Norway Regional Health Authority; Norwegian Society of Nephrology. Norwegian Health Authorities covered expenses associated with paricalcitol Trial registration: NCT01694160 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Generated by independent statistician using computer‐generated block‐randomisation with non‐fixed block size |
| Allocation concealment (selection bias) |
Unclear risk |
Principal investigator performed opening of sealed envelopes. Not reported whether envelopes were opaque or sequentially numbered |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Open‐label |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Open‐label |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No participant was lost to follow‐up |
| Selective reporting (reporting bias) |
High risk |
Patient‐level outcomes including adverse events were not systematically reported |
| Other bias |
Unclear risk |
No additional threats to validity identified |
