Figures & data
Figure 2. Mean baseline-adjusted serum calcifediol concentrations from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).
Asterisk denotes significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.)
![Figure 2. Mean baseline-adjusted serum calcifediol concentrations from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).Asterisk denotes significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.)](/cms/asset/59c31fb2-9f54-4773-b831-b43fc6383e49/iere_a_1347501_f0002_b.gif)
Figure 3. Mean baseline-adjusted serum 1,25-dihydroxyvitamin D from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).
Note: bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.).
![Figure 3. Mean baseline-adjusted serum 1,25-dihydroxyvitamin D from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).Note: bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.).](/cms/asset/ea1d760d-022d-4549-b1cf-92c57286a61b/iere_a_1347501_f0003_b.gif)
Figure 4. Mean baseline-adjusted plasma intact PTH from 0 to 72 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).
Asterisk denotes significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.).
![Figure 4. Mean baseline-adjusted plasma intact PTH from 0 to 72 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).Asterisk denotes significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.).](/cms/asset/70199545-ed5d-4b8d-9253-95ff5a0ecda6/iere_a_1347501_f0004_b.gif)
Figure 5. Mean baseline-adjusted serum 24,25-dihydroxyvitamin D3 concentrations from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).
Asterisks denote significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.)
![Figure 5. Mean baseline-adjusted serum 24,25-dihydroxyvitamin D3 concentrations from 0 to 96 hours after administration of a single dose of Intravenous (IV) or Extended-release (ER) Oral Calcifediol (Phase 2a Study).Asterisks denote significant differences between treatment groups at p < 0.05 and bars indicate standard deviation. (Reprinted with permission from Petkovich 2015, Copyright© 2014 Elsevier Ltd, Amsterdam, the Netherlands.)](/cms/asset/08ff18b6-5fcd-4c86-b424-33d85b4949ca/iere_a_1347501_f0005_b.gif)
Figure 6. Mean (±SE) percent change in PTH from baseline by treatment group at end of treatment (Phase 2b Study). Asterisks denote significant differences between ERC and placebo treatment at p < 0.05 (**) and p < 0.001 (***).
(Reprinted with permission from Sprague 2014, Copyright © 2015 Karger Publishers, Basel, Switzerland.).
![Figure 6. Mean (±SE) percent change in PTH from baseline by treatment group at end of treatment (Phase 2b Study). Asterisks denote significant differences between ERC and placebo treatment at p < 0.05 (**) and p < 0.001 (***).(Reprinted with permission from Sprague 2014, Copyright © 2015 Karger Publishers, Basel, Switzerland.).](/cms/asset/b09f685d-7d8b-469e-bdcf-416ad7ee1d72/iere_a_1347501_f0006_b.gif)
Table 1. Subject end-of-treatment characteristics for phase 2b study (per-protocol subjects).
Figure 7. Response rates for PTH reduction of ≥30% from baseline by treatment group, CKD stage and analysis population in the efficacy assessment period (Phase 3 Pivotal Studies A and B). Asterisks denote significant differences between ERC and placebo treatment at p < 0.05 (*) and p < 0.01 (**).
![Figure 7. Response rates for PTH reduction of ≥30% from baseline by treatment group, CKD stage and analysis population in the efficacy assessment period (Phase 3 Pivotal Studies A and B). Asterisks denote significant differences between ERC and placebo treatment at p < 0.05 (*) and p < 0.01 (**).](/cms/asset/8508d93e-7ccd-4890-94ec-5af7905ca177/iere_a_1347501_f0007_oc.jpg)
Figure 8. Mean (±SE) percent change from baseline over time in PTH by treatment group and Stage 3 (S3) or Stage 4 (S4) in the per protocol population (Phase 3 Pivotal Studies A and B).
![Figure 8. Mean (±SE) percent change from baseline over time in PTH by treatment group and Stage 3 (S3) or Stage 4 (S4) in the per protocol population (Phase 3 Pivotal Studies A and B).](/cms/asset/fa10f4cf-1397-4cc0-b544-6a86de00d16c/iere_a_1347501_f0008_oc.jpg)
Figure 9. Plasma PTH as a function of serum total 25-hydroxyvitamin D (25OHD) in the efficacy assessment period (Pooled Data from Phase 3 Pivotal Studies). Asterisks denote significant differences from 0-20 ng/mL group at p < 0.001 and bars indicate standard error.
![Figure 9. Plasma PTH as a function of serum total 25-hydroxyvitamin D (25OHD) in the efficacy assessment period (Pooled Data from Phase 3 Pivotal Studies). Asterisks denote significant differences from 0-20 ng/mL group at p < 0.001 and bars indicate standard error.](/cms/asset/73cb6648-b336-403e-a213-2a97501817fa/iere_a_1347501_f0009_oc.jpg)
Figure 10. Mean (±SE) percent change from baseline over time in PTH by treatment group and CKD stage in the per protocol population (combined data from Phase 3 pivotal and extension studies).
![Figure 10. Mean (±SE) percent change from baseline over time in PTH by treatment group and CKD stage in the per protocol population (combined data from Phase 3 pivotal and extension studies).](/cms/asset/4b3b4198-db90-4920-8cb7-d9b929337f4b/iere_a_1347501_f0010_oc.jpg)
Table 2. Baseline and end-of-treatment parameters from phase 3 pivotal (Studies A and B) and extension trials (per-protocol subjects).
Table 3. Comparison of effects on blood bone and mineral parameters of ERC versus other vitamin D therapies.