Table 3.
Summary of iron status measurements assessed by serum ferritin and transferrin saturation, hemoglobin, of renal function as assessed by urea (mmol/l), serum creatinine (μmol/l) and eGFR (ml/min per 1.73 m2)
| Variable | IV iron |
na | Placebo |
na | P-valueb | |
|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | |||||
| Serum ferritin (μg/l) | Baseline | 57 (54) | 35 | 62 (33) | 36 | |
| 4 wks | 372 (213) | 31 | 60 (27) | 31 | <0.0001 | |
| 12 wks | 256 (153) | 23 | 78 (53) | 20 | <0.0001 | |
| TSAT (%) | Baseline | 23 (12) | 35 | 21 (6) | 35 | |
| 4 wks | 34 (12) | 29 | 22 (8) | 31 | <0.0001 | |
| 12 wks | 32 (12) | 24 | 22 (8) | 17 | 0.019 | |
| Hb (g/dl) | Baseline | 122.4 (92) | 35 | 127.1 (132) | 36 | |
| 4 wks | 122.9 (160) | 30 | 128.0 (135) | 31 | 0.667 | |
| 12 wks | 130.5 (94) | 23 | 125.4 (148) | 21 | 0.009 | |
| Urea (mmol/l) | Baseline | 12.4 (6.3) | 34 | 10.7 (4.0) | 32 | |
| 4 wks | 11.5 (5.7) | 26 | 11.3 (5.6) | 28 | 0.639 | |
| 12 wks | 10.8 (4.4) | 23 | 10.4 (4.6) | 17 | 0.823 | |
| Serum creatinine (mg/dl) | Baseline | 2.07(0.84) | 36 | 1.88 (0.78) | 36 | |
| 4 wks | 2.22 (0.92) | 30 | 1.99 (0.84) | 32 | 0.597 | |
| 12 wks | 2.06 (0.85) | 24 | 2.07 (0.96) | 21 | 0.011 | |
| eGFR (ml/min per 1.73 m2) | Baseline | 34 (12) | 36 | 35 (11) | 36 | |
| 4 wks | 32 (13) | 30 | 33 (11) | 32 | 0.300 | |
| 12 wks | 36 (14) | 24 | 33 (12) | 21 | 0.085 |
ANCOVA, analysis of covariance; eGFR, estimated glomerular filtration rate; Hb, hemoglobin; IV, intravenous; TSAT, transferrin saturation.
a
Number of patients with complete data at each time point; baseline, 1 month and 3 months.
b
P-value for the treatment effect using ANCOVA analysis where the baseline and the binary stratification variable ferritin (defined as whether baseline ferritin is over 50 μg/l) are used as covariates.