Table 4.
Changes in Markers of Nutrition and Inflammation Among Ferric Citrate and Active Control Participants
| Mean Change From Baselinea |
Adjusted Mean Differences in Mean Changes Between Treatmentsb |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Outcome Variable | FC | AC | SC | CA | SC + CA | FC vs AC | FC vs SC | FC vs CA | FC vs SC + CA |
| Serum albumin (g/dL) | –0.05 ± 0.31 | –0.03 ± 0.33 | –0.03 ± 0.31 | 0.05 ± 0.34 | –0.14 ± 0.35 | –0.01 (–0.08 to 0.05) | –0.01 (–0.09 to 0.07) | –0.09 (–0.20 to 0.02) | 0.09 (–0.04 to 0.22) |
| n = 245; 183 | n = 126; 105 | n = 68; 58 | n = 35; 27 | n = 23; 20 | P = 0.7 | P = 0.7 | P = 0.1 | P = 0.2 | |
| Serum bicarbonate (mmol/L) | 0.88 ± 3.60 | 1.68 ± 4.62 | 1.61 ± 4.92 | 1.12 ± 3.77 | 2.71 ± 4.86 | –0.58 (–1.33 to 0.17) | –0.61 (–1.54 to 0.31) | –0.06 (–1.20 to 1.08) | –1.37 (–2.77 to 0.03) |
| n = 220; 162 | n = 121; 94 | n = 66; 51 | n = 33; 23 | n = 22; 20 | P = 0.1 | P = 0.2 | P = 0.9 | P = 0.06 | |
| SUN (mg/dL) | –4.03 ± 15.50 | –4.53 ± 18.18 | –5.34 ± 16.72 | –0.74 ± 17.36 | –7.91 ± 22.88 | –0.78 (–3.70 to 2.14) | 0.97 (–2.57 to 4.52) | –4.44 (–9.06 to 0.18) | –0.09 (–5.93 to 5.76) |
| n = 243; 182 | n = 126; 105 | n = 68; 58 | n = 35; 27 | n = 23; 20 | P = 0.6 | P = 0.6 | P = 0.06 | P = 0.9 | |
| Serum creatinine (mg/dL) | 0.13 ± 1.67 | –0.06 ± 1.89 | –0.03 ± 1.54 | 0.15 ± 2.53 | –0.45 ± 1.69 | 0.16 (–0.20 to 0.53) | 0.18 (–0.25 to 0.61) | –0.11 (–0.73 to 0.50) | 0.50 (–0.19 to 1.19) |
| n = 244; 183 | n = 126; 105 | n = 68; 58 | n = 35; 27 | n = 23; 20 | P = 0.4 | P = 0.4 | P = 0.7 | P = 0.2 | |
| WBC count (×103) | –0.07 ± 1.51 | –0.02 ± 2.11 | –0.11 ± 2.04 | 0.10 ± 2.37 | 0.09 ± 2.01 | 0.00 (–0.33 to 0.33) | 0.06 (–0.33 to 0.44) | –0.07 (–0.62 to 0.47) | –0.10 (–0.70 to 0.49) |
| n = 248; 188 | n = 132; 111 | n = 72; 62 | n = 35; 27 | n = 25; 22 | P = 0.9 | P = 0.8 | P = 0.8 | P = 0.7 | |
| Lymphocytes/WBCc (%) | –0.24 ± 6.45 | –0.62 ± 8.11 | –1.12 ± 7.42 | 0.25 ± 8.75 | –0.38 ± 9.25 | 0.37 (–0.97 to 1.71) | 0.93 (–0.66 to 2.51) | –0.65 (–2.87 to 1.57) | 0.24 (–2.29 to 2.76) |
| n = 248; 188 | n = 132; 111 | n = 72; 62 | n = 35; 27 | n = 25; 22 | P = 0.6 | P = 0.3 | P = 0.6 | P = 0.9 | |
| Total cholesterol (mg/dL)d | –0.82 ± 32.41 | –15.75 ± 32.99 | –19.78 ± 32.87 | –3.63 ± 34.49 | –22.30 ± 26.97 | 16.83 (10.45 to 23.21) | 21.42 (13.37 to 29.47) | 4.51 (–6.24 to 15.25) | 21.25 (8.50 to 33.99) |
| n = 243; 182 | n = 126; 103 | n = 68; 57 | n = 35; 26 | n = 23; 20 | P < 0.001 | P < 0.001 | P = 0.4 | P = 0.001 | |
| LDL cholesterol (mg/dL)d | –3.19 ± 23.23 | –15.10 ± 27.52 | –20.24 ± 25.93 | –5.20 ± 28.49 | –15.22 ± 27.57 | 13.03 (8.32 to 17.74) | 18.06 (12.37 to 23.75) | 3.07 (–4.64 to 10.78) | 12.78 (3.55 to 22.01) |
| n = 243; 182 | n = 125; 101 | n = 67; 56 | n = 35; 26 | n = 23; 19 | P < 0.001 | P < 0.001 | P = 0.4 | P = 0.007 | |
Note: Conversion factors for units: cholesterol in mg/dL to mmol/L, ×0.02586; creatinine in mg/dL to μmol/L, ×88.4; SUN in mg/dL to mmol/L, ×0.357.
Abbreviations: AC, active control; CA, calcium acetate; FC, ferric citrate; LDL, low-density lipoprotein; SC, sevelamer carbonate; SC + CA, combination of sevelamer carbonate and calcium acetate; SUN, serum urea nitrogen; WBC, white blood cell.
Analyses were 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 represent mean change from baseline ± standard deviation.
Shown are the estimated mean differences (95% confidence interval) in the change from baseline to 12 months between the indicated treatment groups, after adjustment for the baseline measurement of the outcome variable.
Proportion of WBCs that are lymphocytes.
SC versus CA had P = 0.003 for total cholesterol and P = 0.001 for LDL cholesterol.