Table 2.
Changes in Serum Phosphorus, Calcium, and PTH Levels in Ferric Citrate and Active Control Participants Over 52-Week Active Control Study Period
Mean Change From Baselinea |
Adjusted Mean Differences Between Treatmentsb |
||||||||
---|---|---|---|---|---|---|---|---|---|
FC | AC | SC | CA | SC + CA | FC vs AC | FC vs SC | FC vs CA | FC vs SC + CA | |
Phosphorus (mg/dL) | –2.04 ± 1.99 | –2.18 ± 2.25 | –2.11 ± 2.31 | –2.11 ± 1.92 | –2.46 ± 2.52 | 0.01 (–0.30 to 0.33) | 0.02 (–0.38 to 0.41) | 0.05 (–0.46 to 0.57) | –0.04 (–0.64 to 0.57) |
n = 281; 189 | n = 146; 113 | n = 78; 63 | n = 39; 28 | n = 29; 22 | P = 0.9 | P = 0.9 | P = 0.8 | P = 0.9 | |
Calcium (mg/dL) | 0.22 ± 0.90 | 0.31 ± 0.95 | 0.17 ± 0.81 | 0.49 ± 0.96 | 0.41 ± 1.24 | –0.12 (–0.28 to 0.04) | –0.08 (–0.27 to 0.12) | –0.25 (–0.52 to 0.02) | –0.04 (–0.35 to 0.27) |
n = 281; 189 | n = 146; 113 | n = 78; 63 | n = 39; 28 | n = 29; 22 | P = 0.2 | P = 0.5 | P = 0.07 | P = 0.8 | |
PTH (pg/dL) | –167.1 ± 399.8 | –146.5 ± 397.0 | –134.3 ± 419.4 | –98.9 ± 251.3 | –244.5 ± 482.8 | 4.3 (–61.5 to 70.0) | –43.5 (–128.5 to 41.6) | 58.1 (–53.4 to 169.6) | 59.6 (–68.9 to 188.1) |
n = 247; 189 | n = 133; 108 | n = 72; 62 | n = 35; 26 | n = 26; 20 | P = 0.9 | P = 0.3 | P = 0.3 | P = 0.4 |
Abbreviations: AC, active control; CA, calcium acetate; FC, ferric citrate; SC, sevelamer carbonate; SC + CA, combination of sevelamer carbonate and calcium acetate; PTH, parathyroid hormone.
Analyses performed using last-value-carried-forward imputation for missing measurements. Sample sizes indicate the number of patients with nonmissing baseline and follow-up data after the last-value-carried-forward imputation, followed by the sample size for patients with nonmissing baseline and 12-month follow-up measurements. Values present the mean change from baseline ± standard deviation.
Shown are the estimated mean differences (95% confidence interval) in change from baseline to 12 months between the indicated treatment groups after adjustment for baseline measurement of the outcome variable. All P values for comparisons of active control subgroups with each other (CA vs SC, CA vs SC + CA, SC vs SC + CA) were > 0.05.