Table 3.
Patient characteristics of the included publications
Author (year) | Study inclusion in networks | Study arms | Dose | Number of patients | Age | % female | Baseline eGFR (mL/min/1.73m2) | Baseline PTH (pg/mL) | Baseline calcium (mg/dL) | Baseline phosphate (mg/dL) | Baseline vitamin D (25(OH)D) (ng/mL) |
---|---|---|---|---|---|---|---|---|---|---|---|
Panel A: Publications comparing extended-release calcifediol to placebo | |||||||||||
Sprague (2014) (17) | PTH, Ca, P | ER calcifediol | 30 µg/day | 13 | 58.2 | 53.8 | 36.7 | 156.3 | 9.3 | 3.8 | 21.1 |
ER calcifediol | 60 µg/day | 17 | 64.7 | 41.2 | 42.6 | 118.5 | 9.3 | 3.6 | 23.6 | ||
Placebo | NA | 31 | 62.8 | 64.5 | 38.7 | 145.7 | 9.4 | 3.5 | 19.7 | ||
Sprague (2016) (20) | PTH, Ca, P | ER calcifediol | 30 µg/day for weeks 0-12 with possible up titration to 60 µg/day weeks 13-26, based on levels of PTH, 25(OH)D and calcium | 285 | 66.0 | 49.8 | 30.6 | 147.2 | 9.2 | 3.7 | 19.9 |
Placebo | NA | 144 | 64.9 | 50.0 | 32.0 | 148.9 | 9.2 | 3.8 | 19.3 | ||
Summary Panel A: | 507 (sum) | 63.7 (average) | 52.0 (average) | 36.3 (average) | 144.0 (average) | 9.3 (average) | 3.7 (average) | 19.9 | |||
Panel B: Publications comparing paricalcitol to placebo | |||||||||||
Alborzi (2008) (16) | PTH | Paricalcitol | 1 µg/day | 8 | 72.6 | 25.0 | 47.5 | 66.8 | 9.5 | 3.2 | N/A |
Paricalcitol | 2 µg/day | 8 | 67.5 | 25.0 | 47.4 | 76.0 | 9.5 | 3.3 | N/A | ||
Placebo | NA | 8 | 68.4 | 0.0 | 44.0 | 124.9 | 9.3 | 3.4 | N/A | ||
Coyne (2006) (15) | Ca, P | Paricalcitol | Starting dose 1 µg/day or 2 µg thrice weekly if PTH <500 pg/mL or 2 µg/day or 4 µg thrice weekly if PTH ≥500 pg/mL, with subsequent dose titration based on levels of PTH, calcium and phosphate (average daily dose of 1.36 µg/day) | 107 | 63.6 | 32.0 | 23.1 | 265.0 | 9.3 | 4.0 | N/A |
Placebo | NA | 113 | 61.8 | 33.0 | 23.0 | 280.0 | 9.4 | 4.0 | N/A | ||
Coyne (2013) (18) | PTH, Ca, P | Paricalcitol | 1 µg/day | 93 | 64.0 | 29.0 | 40.0 | 97.0 | 9.3 | 3.9 | N/A |
Paricalcitol | 2 µg/day | 95 | 65.0 | 27.0 | 42.0 | 91.0 | 9.4 | 3.8 | N/A | ||
Placebo | NA | 93 | 65.0 | 35.0 | 39.0 | 105.0 | 9.3 | 3.8 | N/A | ||
Lundwall (2015) (19) | PTH, Ca, P | Paricalcitol | 1 µg/day | 12 | 66.1 | 8.0 | 38.9 | 68.8 | 9.1 | 3.4 | 28.7 |
Paricalcitol | 2 µg/day | 12 | 70.8 | 33.0 | 42.1 | 66.0 | 9.1 | 3.4 | 27.8 | ||
Placebo | NA | 12 | 59.1 | 25.0 | 41.6 | 87.7 | 9.1 | 3.1 | 25.9 | ||
Thadhani (2012) (5) | PTH, Ca, P | Paricalcitol | Starting dose 2 µg/d with possible downtitration to 1 µg/d based on levels of calcium | 115 | 64.0 | 31.3 | 36.01 | 100.01 | 9.61 | 3.71 | N/A |
Placebo | NA | 112 | 66.0 | 29.5 | 31.01 | 106.01 | 9.61 | 3.51 | N/A | ||
Wang (2014) (6) | PTH, Ca, P | Paricalcitol | Starting dose 1 µg/d if PTH <500 pg/mL or 2 µg/d if PTH ≥500 pg/mL, with subsequent dose titration based on levels of calcium | 30 | 60.8 | 34.0 | 23.91 | 156.01 | 9.3 | 4.2 | N/A |
Placebo | NA | 30 | 62.2 | 53.0 | 19.71 | 158.01 | 9.4 | 3.9 | N/A | ||
Zoccali (2014) (4) | PTH, Ca, P | Paricalcitol | starting dose 2 µg/d with possible downtitration to 1 µg every other day based on levels of PTH and calcium | 44 | 60.8 | 41.0 | 34.0 | 102.01 | 9.0 | 3.7 | 13.2 |
Placebo | NA | 44 | 62.0 | 30.0 | 29.0 | 102.01 | 8.9 | 3.8 | 15.2 | ||
Summary Panel B: | 936 (sum) | 64.7 (average) | 28.9 (average) | 35.4 (average) | 120.7 (average) | 9.3 (average) | 3.7 (average) | 18.1 | |||
Summary all studies: | 1443 (sum) | 64.4 (average) | 34.9 (average) | 35.7 (average) | 126.8 (average) | 9.3 (average) | 3.7 (average) | 19.5 |
Abbreviations: 25(OH)D, 25-hydroxyvitamin D; eGFR, estimated glomerular filtration rate; ER, extended-release; PTH, parathyroid hormone.