Background
Methods
Measurements
6H syndrome markers
Bone turnover markers
Hematinic response
Kidney function/injury
Inflammation
Statistical analysis
Results
Baseline
Variable | Iron group | Value | p-value |
---|---|---|---|
Age* / years | Total | 67.9 (12.4) | 0.043 |
FDI | 63.4 (12.2) | ||
FCM | 73.2 (10.8) | ||
Body mass index / kg/m2 | Total | 27.8 (25.0–33.4) | 0.279 |
FDI | 28.8 (26.2–36.3) | ||
FCM | 26.8 (23.0–32.7) | ||
iFGF23 / pg/ml | Total | 212.1 (145.1–311.6) | 0.212 |
FDI | 257.3 (136.2–584.6) | ||
FCM | 186.5 (143.6–226.6) | ||
Phosphate / mmol/L | Total | 1.28 (1.12–1.43) | 0.193 |
FDI | 1.30 (1.16–1.59) | ||
FCM | 1.20 (1.07–1.38) | ||
Hemoglobin* / g/L | Total | 100.3 (13.5) | 0.664 |
FDI | 99.2 (12.2) | ||
FCM | 101.6 (15.3) | ||
Serum Ferritin / µg/L | Total | 76.5 (38.7–157.5) | 0.899 |
FDI | 76.5 (25.0–183.5) | ||
FCM | 72.7 (42.3–146.9) | ||
Transferrin saturation / % | Total | 15.0 (11.7–18.5) | 0.781 |
FDI | 15.0 (11.0–21.0) | ||
FCM | 14.5 (12.0–17.8) | ||
Creatinine* / µmol/L | Total | 269.5 (88.2) | 0.626 |
FDI | 277.6 (98.8) | ||
FCM | 260.2 (77.3) | ||
eGFR / ml/min/1.73m2 | Total | 18.0 (14.0–25.3) | 1.000 |
FDI | 18.0 (14.0–25.3) | ||
FCM | 18.0 (14.0–25.3) | ||
CRP / mg/L | Total | 7.4 (3.3–17.3) | 0.462 |
FDI | 8.0 (3.2–20.8) | ||
FCM | 4.3 (3.4–13.4) | ||
urinary PCR / mg/mmol | Total | 87.5 (30.0–341.3) | 0.082 |
FDI | 155.0 (57.5–607.5) | ||
FCM | 30.0 (20.0–310.0) | ||
1,25 (OH)2 Vitamin D* / pmol/L | Total | 45.6 (22.2) | 0.290 |
FDI | 41.3 (20.8) | ||
FCM | 50.7 (23.5) | ||
25 (OH)2 Vitamin D / nmol/L | Total | 57.4 (22.4–86.0) | 0.252 |
FDI | 44.2 (18.3–83.1) | ||
FCM | 67.5 (29.9–97.0) | ||
24(R),25 (OH)2 Vitamin D / nmol/L | Total | 2.2 (0.6–3.4) | 0.631 |
FDI | 1.2 (0.5–4.5) | ||
FCM | 2.9 (0.9–3.2) | ||
Calcium* / mmol/L | Total | 2.35 (0.08) | 0.813 |
FDI | 2.35 (0.08) | ||
FCM | 2.34 (0.09) | ||
PTH / pmol/L | Total | 17.4 (11.3–22.6) | 0.145 |
FDI | 18.9 (12.9–28.8) | ||
FCM | 16.3 (7.9–20.9) | ||
24 hr. urinary phosphate / mmol | Total | 17.5 (11.0–22.3) | 0.023 |
FDI | 21.0 (15.0–23.5) | ||
FCM | 12.5 (10.3–17.8) | ||
Fractional excretion of phosphate/ % | Total | 43.2 (32.9–55.6) | 0.374 |
FDI | 49.7 (32.2–58.3) | ||
FCM | 36.4 (32.9–54.5) | ||
ALP / [iU]/L | Total | 97.0 (79.0–144.3) | 0.667 |
FDI | 96.0 (79.0–153.0) | ||
FCM | 107.0 (77.8–129.8) | ||
BALP / [U]/L | Total | 19.5 (15.0–26.4) | 0.462 |
FDI | 21.3 (16.6–26.8) | ||
FCM | 18.7 (14.1–27.5) | ||
CTx / µg/ml | Total | 0.89 (0.52–1.07) | 0.560 |
FDI | 0.84 (0.56–1.01) | ||
FCM | 0.98 (0.49–1.18) | ||
P1NP / µg/L | Total | 103.0 (63.0–174.3) | 0.820 |
FDI | 112.0 (70.3–178.8) | ||
FCM | 103.0 (63.0–166.3) |
Variable | Total | FDI | FCM | P-value |
---|---|---|---|---|
Gender | ||||
Male | 17 (65.3) | 8 (57.1) | 9 (75.0) | |
Female | 9 (34.6) | 6 (42.8) | 3 (25.0) | 0.429 |
Smoking status | ||||
Smoker | 7 (27.0) | 5 (35.7) | 2 (16.7) | |
Ex-smoker | 14 (53.8) | 5 (35.7) | 9 (75.0) | |
Non-smoker | 5 (19.2) | 4 (28.6) | 1 (8.3) | N/A |
CKD stage | ||||
3b | 3 (11.5) | 1 (7.1) | 2 (16.7) | |
4 | 16 (61.5) | 9 (64.3) | 7 (58.3) | |
5 | 7 (26.9) | 4 (28.6) | 3 (25.0) | N/A |
Ethnicity | ||||
White | 26 (100.0) | 14 (100.0) | 12 (100.) | |
Black | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Other | 0 (0.0) | 0 (0.0) | 0 (0.0) | N/A |
Hypertension | 21 (80.8) | 13 (92.9) | 8 (66.7) | 0.148 |
Type I Diabetes Mellitus | 2 (7.7) | 2 (14.3) | 0 (0.0) | 0.483 |
Type II Diabetes Mellitus | 11 (42.3) | 6 (42.8) | 5 (41.7) | 1.000 |
Heart failure | 7 (26.9) | 1 (7.1) | 6 (50.0) | 0.0026 |
Ischemic Heart disease | 10 (38.5) | 4 (28.6) | 6 (50.0) | 0.422 |
Previous cancer | 5 (19.2) | 2 (14.3) | 3 (25.0) | 0.635 |
Medications | ||||
Erythropoiesis stimulating agents | 8 (30.8) | 5 (35.7) | 3 (25.0) | 0.683 |
Renin-angiotensin-aldosterone system associated medications | 16 (61.5) | 9 (64.3) | 7 (58.3) | 1.000 |
Vitamin D supplementation | 6 (23.1) | 4 (28.6) | 2 (16.7) | 0.652 |
Diuretics | 14 (53.8) | 7 (50.0) | 7 (58.3) | 0.713 |
ß-blockers | 18 (69.2) | 9 (64.3) | 9 (75.0) | 0.683 |
Cause | ||||
Autosomal Dominant Polycystic Kidney Disease | 1 (3.8) | 1 (7.1) | 0 (0.0) | N/A |
Multifactorial | 6 (23.1) | 2 (14.3) | 4 (33.3) | N/A |
Primary renovascular | 2 (7.7) | 1 (7.1) | 1 (8.3) | N/A |
Glomerulosclerosis | 1 (3.8) | 0 (0.0) | 1 (8.3) | N/A |
Unknown | 1 (3.8) | 1 (7.1) | 0 (0.0) | N/A |
Diabetic nephropathy | 3 (11.5) | 2 (14.3) | 1 (8.3) | N/A |
IgA nephropathy | 2 (7.7) | 1 (7.1) | 1 (8.3) | N/A |
Nephrectomy | 1 (3.8) | 0 (0.0) | 1 (8.3) | N/A |
Kidney aplasia and obstructive uropathy | 1 (3.8) | 1 (7.1) | 0 (0.0) | N/A |
Chronic pyelonephritis | 1 (3.8) | 1 (7.1) | 0 (0.0) | N/A |
Membranous nephropathy | 3 (11.5) | 3 (21.4) | 0 (0.0) | N/A |
Cardiorenal syndrome | 2 (7.7) | 0 (0.0) | 2 (16.7) | N/A |
Hypertension | 1 (3.8) | 1 (7.1) | 0 (0.0) | N/A |
Systemic Lupus Erythematosus | 1 (3.8) | 0 (0.0) | 1 (8.3) | N/A |
Intact FGF23 and phosphate
Variable | Iron group (n) | Mean/Median (SD/IQR) | p-value |
---|---|---|---|
iFGF23 | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | 3.0 (28.9) | |
FCM (11) | 146.1 (94.9) | < 0.001 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | 11.9 (40.6) | |
FCM (10) | 24.3 (52.7) | 0.284 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | 6.5 (30.3) | |
FCM (11) | 17.1 (32.3) | 0.566 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | 3.2 (28.9) | |
FCM (10) | 235.1 (296.1) | 0.001 | |
Baseline to 2 months after 1st infusion | FDI (12) | 15.7 (104.7) | |
FCM (10) | 8.1 (62.1) | 0.497 | |
Phosphate | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | -6.5 (15.1) | |
FCM (11) | -3.3 (18.2) | 0.893 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | -1.6 (20.6) | |
FCM (10) | -11.0 (17.8) | 0.077 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | -7.5 (25.1) | |
FCM (11) | -6.1 (14.3) | 1.000 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | 1.8 (30.3) | |
FCM (10) | -14.9 (14.7) | 0.013 | |
Baseline to 2 months after 1st infusion | FDI (13) | 9.2 (25.1) | |
FCM (10) | -13.2 (18.5) | 0.131 | |
Calcium a | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | 1.5 (2.7) | |
FCM (11) | 0.4 (2.5) | 0.297 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | 0.4 (3.4) | |
FCM (10) | -1.8 (3.1) | 0.131 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | 0.5 (2.9) | |
FCM (11) | 0.3 (3.8) | 0.916 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | 1.5 (2.2) | |
FCM (10) | -1.0 (2.4) | 0.035 | |
Baseline to 2 months after 1st infusion | FDI (12) | 0.5 (4.7) | |
FCM (10) | 1.5 (3.2) | 0.566 | |
Fractional excretion of phosphate | |||
Baseline to 1–2 days after 1st infusion | FDI (11) | -7.1 (26.2) | |
FCM (10) | 6.4 (27.9) | 0.314 | |
Baseline to 2 weeks after 1st infusion | FDI (12) | -3.7 (18.1) | |
FCM (10) | -5.0 (28.9) | 0.872 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (9) | -2.7 (13.0) | |
FCM (10) | 3.6 (33.9) | 0.661 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | -8.2 (31.6) | |
FCM (10) | 13.0 (48.4) | 0.182 | |
Baseline to 2 months after 1st infusion | FDI (10) | 5.0 (24.8) | |
FCM (10) | 0.3 (28.0) | 1.000 | |
1,25 (OH)2 Vitamin D a | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | -2.8 (14.2) | |
FCM (11) | -15.6 (12.8) | 0.027 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | -14.7 (14.6) | |
FCM (10) | -18.1 (14.9) | 0.580 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | -9.8 (16.5) | |
FCM (11) | -5.4 (27.2) | 0.642 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | -4.7 (13.0) | |
FCM (10) | -24.9 (22.5) | 0.031 | |
Baseline to 2 months after 1st infusion | FDI (12) | -5.4 (30.5) | |
FCM (10) | -5.3 (29.1) | 0.933 | |
25 (OH)2 Vitamin D | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | 1.6 (14.0) | |
FCM (11) | -3.5 (17.5) | 0.267 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | 5.8 (17.7) | |
FCM (10) | -0.3 (10.6) | 0.483 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | -11.0 (28.8) | |
FCM (11) | -7.1 (26.0) | 0.880 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | 0.8 (20.0) | |
FCM (10) | -8.5 (21.7) | 0.549 | |
Baseline to 2 months after 1st infusion | FDI (12) | -1.0 (48.8) | |
FCM (10) | -3.0 (25.7) | 0.923 | |
24(R), 25 (OH)2 Vitamin D | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | 0.0 (7.7) | |
FCM (11) | -8.3 (14.3) | 0.085 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | 0.0 (7.3) | |
FCM (10) | 12.0 (21.1) | 0.067 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | -4.2 (29.3) | |
FCM (11) | 13.5 (37.5) | 0.695 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | -3.0 (21.6) | |
FCM (10) | 6.3 (27.8) | 0.842 | |
Baseline to 2 months after 1st infusion | FDI (12) | 0.0 (48.4) | |
FCM (10) | -4.1 (26.8) | 0.923 | |
PTH a | |||
Baseline to 1–2 days after 1st infusion | FDI (14) | -7.8 (22.0) | |
FCM (11) | -6.9 (25.4) | 0.927 | |
Baseline to 2 weeks after 1st infusion | FDI (13) | 2.9 (30.8) | |
FCM (10) | 19.6 (32.9) | 0.226 | |
Baseline to 1 month after 1st infusion (2nd infusion) | FDI (12) | -12.1 (32.0) | |
FCM (11) | 13.6 (27.7) | 0.054 | |
Baseline to 1–2 days after 2nd infusion | FDI (9) | -3.7 (29.5) | |
FCM (10) | -5.0 (24.3) | 0.913 | |
Baseline to 2 months after 1st infusion | FDI (12) | 1.8 (36.7) | |
FCM (10) | -1.6 (28.1) | 0.810 |
Visit | Iron group (n) | Mean/Median (SD/IQR) | p-value | p- value (within group analysis) |
---|---|---|---|---|
iFGF23 | ||||
Baseline | FDI (14) | 257.3 (136.2–584.6) pg/ml | 0.212 | |
FCM (12) | 186.5 (143.6–226.6) pg/ml | |||
1–2 days post 1st infusion | FDI (14) | 251.0 (156.6–583.0) pg/ml | 0.066 | |
FCM (11) | 467.1 (334.6–655.7) pg/ml | |||
2 weeks | FDI (13) | 233.6 (161.0–417.6) pg/ml | 0.410 | |
FCM (10) | 199.7 (144.4–329.1) pg/ml | |||
1 month (2nd infusion) | FDI (12) | 226.5 (137.2–428.9) pg/ml | 0.487 | |
FCM (11) | 212.1 (116.0–253.7) pg/ml | |||
1–2 days post 2nd infusion | FDI (9) | 262.4 (129.1–468.1) pg/ml | 0.035 | |
FCM (10) | 662.7 (375.9–1633.8) pg/ml | |||
2 months | FDI (12) | 301.2 (144.4–533.9) pg/ml | 0.497 | Within FDI: 0.058 |
FCM (10) | 227.8 (165.3–285.3) pg/ml | Within FCM 0.001 | ||
Phosphate | ||||
Baseline | FDI (14) | 1.30 (1.16–1.59) mmol/L | 0.193 | |
FCM (12) | 1.20 (1.07–1.38) mmol/L | |||
1–2 days post 1st infusion | FDI (14) | 1.37 (1.12–1.58) mmol/L | 0.647 | |
FCM (11) | 1.23 (1.04–1.35) mmol/L | |||
2 weeks | FDI (13) | 1.26 (1.05–1.66) mmol/L | 0.049 | |
FCM (10) | 1.09 (0.94–1.23) mmol/L | |||
1 month (2nd infusion) | FDI (12) | 1.18 (1.07–1.57) mmol/L | 0.449 | |
FCM (11) | 1.14 (0.95–1.31) mmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 1.23 (1.15–1.66) mmol/L | 0.065 | |
FCM (10) | 1.11 (0.91–1.36) mmol/L | |||
2 months | FDI (13) | 1.33 (1.13–1.67) mmol/L | 0.057 | Within FDI: 0.278 |
FCM (10) | 1.13 (1.00–1.22) mmol/L | Within FCM: 0.129 | ||
Calcium a | ||||
Baseline | FDI (14) | 2.35 (0.08) mmol/L | 0.813 | |
FCM (12) | 2.34 (0.09) mmol/L | |||
1–2 days post 1st infusion | FDI (14) | 2.39 (0.11) mmol/L | 0.286 | |
FCM (11) | 2.34 (0.10) mmol/L | |||
2 weeks | FDI (13) | 2.36 (0.11) mmol/L | 0.123 | |
FCM (10) | 2.29 (0.06) mmol/L | |||
1 month (2nd infusion) | FDI (12) | 2.35 (0.09) mmol/L | 0.698 | |
FCM (11) | 2.32 (0.08) mmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 2.38 (0.10) mmol/L | 0.063 | |
FCM (10) | 2.31 (0.06) mmol/L | |||
2 months | FDI (13) | 2.35 (0.11) mmol/L | 0.807 | Within FDI: 0.473 |
FCM (10) | 2.36 (0.07) mmol/L | Within FCM: 0.544 | ||
Fractional excretion of phosphate | ||||
Baseline | FDI (14) | 49.7 (32.2–58.3) % | 0.374 | |
FCM (12) | 36.4 (32.9–54.5) % | |||
1–2 days post 1st infusion | FDI (11) | 41.8 (31.4–51.5) % | 0.918 | |
FCM (10) | 41.3 (34.9–50.1) % | |||
2 weeks | FDI (12) | 41.9 (30.2–47.8) % | 0.722 | |
FCM (10) | 40.8 (28.8–53.6) % | |||
1 month (2nd infusion) | FDI (9) | 40.3 (30.1–53.1) % | 0.968 | |
FCM (10) | 42.6 (28.2–53.6) % | |||
1–2 days post 2nd infusion | FDI (8) | 40.1 (27.2–50.2) % | 0.897 | |
FCM (10) | 40.3 (28.2–50.7) % | |||
2 months | FDI (10) | 48.3 (28.5–54.8) % | 0.631 | Within FDI: 0.927 |
FCM (10) | 42.2 (31.0–47.4) % | Within FCM: 0.412 | ||
1,25 (OH)2 Vitamin D a | ||||
Baseline | FDI (14) | 41.3 (20.8) pmol/L | 0.290 | |
FCM (12) | 50.7 (23.5) pmol/L | |||
1–2 days post 1st infusion | FDI (14) | 41.0 (25.6) pmol/L | 0.702 | |
FCM (11) | 44.8 (21.9) pmol/L | |||
2 weeks | FDI (13) | 37.5 (18.6) pmol/L | 0.841 | |
FCM (10) | 39.0 (15.1) pmol/L | |||
1 month (2nd infusion) | FDI (12) | 40.0 (20.5) pmol/L | 0.398 | |
FCM (11) | 47.5 (20.9) pmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 45.8 (42.2) pmol/L | 0.283 | |
FCM (10) | 36.2 (12.6) pmol/L | |||
2 months | FDI (12) | 41.9 (22.2) pmol/L | 0.491 | Within FDI: 0.264 |
FCM (10) | 49.0 (25.3) pmol/L | Within FCM: 0.026 | ||
25(OH)2 Vitamin D | ||||
Baseline | FDI (14) | 44.2 (18.3–83.1) nmol/L | 0.252 | |
FCM (12) | 67.5 (29.9–97.0) nmol/L | |||
1–2 days post 1st infusion | FDI (14) | 44.9 (18.7–83.7) nmol/L | 0.467 | |
FCM (11) | 54.5 (22.1–87.1) nmol/L | |||
2 weeks | FDI (13) | 45.2 (17.3–90.8) nmol/L | 0.832 | |
FCM (10) | 69.0 (22.2–89.8) nmol/L | |||
1 month (2nd infusion) | FDI (12) | 35.7 (15.9–83.7) nmol/L | 0.235 | |
FCM (11) | 68.1 (26.3–102.1) nmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 57.8 (20.5–88.3) nmol/L | 0.604 | |
FCM (10) | 63.3 (25.5–97.0) nmol/L | |||
2 months | FDI (12) | 47.4 (19.2–93.2) nmol/L | 0.346 | Within FDI: 0.945 |
FCM (10) | 70.2 (28.9–112.3) nmol/L | Within FCM: 0.977 | ||
24(R),25 (OH)2 Vitamin D | ||||
Baseline | FDI (14) | 1.2 (0.5–4.5) nmol/L | 0.631 | |
FCM (12) | 2.9 (0.9–3.2) nmol/L | |||
1–2 days post 1st infusion | FDI (14) | 1.2 (0.6–4.2) nmol/L | 0.727 | |
FCM (11) | 2.5 (0.8–3.3)) nmol/L | |||
2 weeks | FDI (13) | 1.2 (0.6–4.3) nmol/L | 0.693 | |
FCM (10) | 3.1 (0.7–3.9) nmol/L | |||
1 month (2nd infusion) | FDI (12) | 1.0 (0.5–3.6) nmol/L | 0.347 | |
FCM (11) | 2.6 (0.7–3.8) nmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 1.7 (0.7–4.1) nmol/L | 1.000 | |
FCM (10) | 2.9 (0.9–3.6) nmol/L | |||
2 months | FDI (12) | 1.3 (0.5–4.8) nmol/L | 0.539 | Within FDI: 0.902 |
FCM (10) | 2.8 (0.9–3.5) nmol/L | Within FCM: 0.406 | ||
PTH | ||||
Baseline | FDI (14) | 18.9 (12.9–28.8) pmol/L | 0.145 | |
FCM (12) | 16.3 (7.9–20.9) pmol/L | |||
1–2 days post 1st infusion | FDI (14) | 16.2 (10.8–27.9) pmol/L | 0.344 | |
FCM (11) | 13.2 (7.2–18.8) pmol/L | |||
2 weeks | FDI (13) | 19.6 (8.3–34.5) pmol/L | 0.564 | |
FCM (10) | 17.2 (10.5–20.1) pmol/L | |||
1 month (2nd infusion) | FDI (12) | 18.2 (7.2–28.4) pmol/L | 0.651 | |
FCM (11) | 17.5 (9.6–22.6) pmol/L | |||
1–2 days post 2nd infusion | FDI (9) | 14.4 (7.4–25.8) pmol/L | 0.604 | |
FCM (10) | 13.4 (7.6–17.5) pmol/L | |||
2 months | FDI (12) | 20.2 (8.9–22.1) pmol/L | 0.283 | Within FDI: 0.299 |
FCM (10) | 12.8 (8.1–20.1) pmol/L | Within FCM: 0.081 |
Other markers of 6H syndrome
Bone turnover markers
Visit | Iron group (n) | Median (IQR) | p-value | p- value (within group analysis) |
---|---|---|---|---|
ALP | ||||
Baseline | FDI (14) | 96.0 (79.0–153.0) [iU]/L | 0.667 | |
FCM (12) | 107.0 (77.8–129.8) [iU]/L | |||
1–2 days post 1st infusion | FDI (14) | 104.0 (82.5–159.5) [iU]/L | 0.893 | |
FCM (11) | 110.0 (82.0–150.0) [iU]/L | |||
2 weeks | FDI (13) | 110.0 (74.0–136.5) [iU]/L | 0.832 | |
FCM (10) | 112.5 (90.5–139.0) [iU]/L | |||
1 month (2nd infusion) | FDI (12) | 99.5 (78.2–131.5) [iU]/L | 0.525 | |
FCM (11) | 112.0 (90.0–140.0) [iU]/L | |||
1–2 days post 2nd infusion | FDI (9) | 110.0 (78.0–136.0) [iU]/L | 0.604 | |
FCM (10) | 123.5 (87.5–152.8) [iU]/L | |||
2 months | FDI (13) | 124.0 (90.0–145.0) [iU]/L | 0.879 | Within FDI: 0.427 |
FCM (10) | 118.0 (90.7–168.0) [iU]/L | Within FCM: 0.016 | ||
BALP | ||||
Baseline | FDI (14) | 21.3 (16.6–26.8) [U]/L | 0.462 | |
FCM (12) | 18.7 (14.1–27.5) [U]/L | |||
1–2 days post 1st infusion | FDI (14) | 18.6 (15.7–26.7) [U]/L | 0.767 | |
FCM (11) | 17.0 (12.6–31.8) [U]/L | |||
2 weeks | FDI (13) | 20.4 (16.6–23.8) [U]/L | 0.738 | |
FCM (10) | 17.9 (16.7–24.1) [U]/L | |||
1 month (2nd infusion) | FDI (12) | 20.6 (15.0–24.2) [U]/L | 0.740 | |
FCM (11) | 18.5 (17.1–35.4) [U]/L | |||
1–2 days post 2nd infusion | FDI (9) | 20.9 (15.7–27.8) [U]/L | 0.905 | |
FCM (10) | 19.9 (16.7–35.1) [U]/L | |||
2 months | FDI (12) | 19.8 (17.6–25.0) [U]/L | 0.203 | Within FDI: 0.883 |
FCM (10) | 22.9 (19.9–28.8) [U]/L | Within FCM < 0.001 | ||
CTx | ||||
Baseline | FDI (14) | 0.84 (0.56–1.01) µg/ml | 0.560 | |
FCM (12) | 0.98 (0.49–1.18) µg/ml | |||
1–2 days post 1st infusion | FDI (14) | 0.81 (0.51–0.97 µg/ml | 0.767 | |
FCM (11) | 0.73 (0.44–1.19) µg/ml | |||
2 weeks | FDI (13) | 0.77 (0.55–0.87) µg/ml | 0.927 | |
FCM (10) | 0.69 (0.51–1.05) µg/ml | |||
1 month (2nd infusion) | FDI (12) | 0.74 (0.49–.105) µg/ml | 0.316 | |
FCM (11) | 0.99 (0.58–1.32) µg/ml | |||
1–2 days post 2nd infusion | FDI (9) | 0.71 (0.46–0.84) µg/ml | 0.211 | |
FCM (10) | 0.88 (0.50–1.17) µg/ml | |||
2 months | FDI (12) | 0.84 (0.50–1.13) µg/ml | 0.582 | Within FDI: 0.905 |
FCM (10) | 0.94 (0.60–1.48) µg/ml | Within FCM: 0.006 | ||
P1NP | ||||
Baseline | FDI (14) | 112.0 (70.3–178.8) µg/L | 0.820 | |
FCM (12) | 103.0 (63.0–166.3) µg/L | |||
1–2 days post 1st infusion | FDI (14) | 108.0 (63.6–156.8) µg/L | 0.767 | |
FCM (11) | 89.0 (55.0–164.0) µg/L | |||
2 weeks | FDI (13) | 107.0 (64.0–126.0) µg/L | 0.784 | |
FCM (10) | 77.5 (56.3–158.8) µg/L | |||
1 month (2nd infusion) | FDI (12) | 98.0 (63.0–118.0) µg/L | 0.748 | |
FCM (11) | 85.0 (56.0–166.0) µg/L | |||
1–2 days post 2nd infusion | FDI (9) | 80.0 (50.5–116.0) µg/L | 0.780 | |
FCM (10) | 71.0 (56.7–174.5) µg/L | |||
2 months | FDI (12) | 97.0 (50.8–156.5) µg/L | 0.722 | Within FDI: 0.439 |
FCM (10) | 104.5 (55.3–181.8) µg/L | Within FCM: 0.459 |