Table 2.
Key results
| Baseline | Week 24 | Treatment effect with 95% CI (or OR) (at week 24) |
P-value | |||
|---|---|---|---|---|---|---|
| Placebo (n = 21) | FCM (n = 18) | Placebo (n = 18) | FCM (n = 17) | |||
| Primary endpoint | ||||||
| 6 min walk test distance (m) | 325 (250–342) | 308 (198–378) | 308 (285–354) Change from BL to w24: −7.8 ± 60.6 | 403 (306–416) Change from BL to w24: 44.9 ± 61.9 | 49 (5.1, 93.0) | .029 |
| Secondary endpoints | ||||||
| Patient global assessment | - | - | Much worse: 1 Worse: 1 Little worse: 2 Unchanged: 6 Little improved: 5 Improved: 3 Much improved: 0 |
Much worse: 0 Worse: 1 Little worse: 2 Unchanged: 9 Little improved: 0 Improved: 4 Much improved: 1 |
OR 0.924 (0.24, 3.51) | .91 |
| NYHA class | 2.52 ± 0.51 II: 10 III: 11 |
2.38 ± 0.50 II: 11 III: 7 |
2.50 ± 0.51 II: 9 III: 9 |
2.35 ± 0.49 II: 11 III: 6 |
−0.03 (−0.32, 0.26) | .83 |
| EQ-5D-3L | 0.68 (0.59–0.76) | 0.62 (0.50–0.71) | 0.69 (0.60–0.78) | 0.68 (0.50–0.78) | −0.03 (−0.14, 0.09) | 0.63 |
| KCCQ overall summary score | 72 (50–77) | 50 (36–66) | 70 (54–82) Change from BL to w24: 0.49 ± 14.81 | 60 (56–81) Change from BL to w24: 12.41 ± 11.53 | 6.5 (−3.8, 16.7) | .21 |
| eGFR (mL/min/1.73 m2) | 59 (36–76) | 40 (32–66) | 50 (35–72) | 47 (38–63) | 0.27 (−7.16, 7.70) | .94 |
| C-reactive protein (mg/L) | 2.9 (1.3–6.7) | 2.1 (1.8–6.1) | 2.5 (0.8–5.0) | 2.3 (1.5–8.3) | −8.2 (−32.6, 16.2) | .50 |
| Other endpoints and biomarker assessments | ||||||
| Haemoglobin (g/dL) | 12.0 (11.4–12.8) | 12.9 (11.7–13.2) | 12.1 (11.2–13.1) | 13.8 (13.4–14.2) | 0.93 (0.10, 1.76) | .028 |
| Ferritin (µg/L) | 50 (25–94) | 44 (23–72) | 46 (29–78) | 326 (238–402) | 215 (141, 289) | <.001 |
| TSAT (%) | 16.0 (14.0–21.0) | 19.9 (13.8–24.8) | 19.0 (13.5–23.0) | 30.0 (24.5–35.6) | 9.7 (3.9, 15.5) | .001 |
| Systolic blood pressure (mmHg) | 125 (111–136) | 127 (113–151) | 130 (113–135) | 127 (118–139) | 1 (−10.3, 12.6) | .84 |
| Diastolic blood pressure (mmHg) | 67 (62 –72) | 75 (63–81) | 71 (64–77) | 71 (63–79) | −4 (−10.3, 3.0) | .28 |
| Heart rate (b.p.m.) | 68 (61–80) | 68 (60–71) | 74 (64–82) | 66 (60–67) | −4 (−12, 33) | .26 |
| ASAT (U/L) | 24 (22–27) | 25 (22–28) (n = 17) |
24 (21–31) | 26 (23–27) (n = 16) |
−0.2 (−8.3, 8.7) | .96 |
| ALAT (U/L) | 19 (15–24) | 16 (14–22) (n = 17) |
20 (17–25) | 22 (17–28) (n = 16) |
2.4 (−3.0, 7.8) | .38 |
| γ−GT (U/L) | 27 (17–46) | 31 (19–53) (n = 17) |
30 (16–52) | 54 (33–105) (n = 16) |
21.4 (−5.4, 48.3) | .12 |
| Creatinine (mg/dL) | 1.1 (0.8–1.5) | 1.3 (1.0–1.6) | 1.1 (0.9–1.5) | 1.2 (1.1–1.6) | −0.09 (−0.23, 0.16) | .53 |
| Blood urea nitrogen (mg/dL) | 9.8 (7.5–18.2) (n = 9) |
18.9 (9.7–32.8) (n = 6) |
11.8 (9.7–15.6) (n = 8) |
19.2 (10.3–45.7) (n = 9) |
0.1 (−10.8, 11.1) | .98 |
BL, baseline; OR, odds ratio.