Efficacy and Safety of Evocalcet Evaluated by Dialysate Calcium Concentration in Patients with Secondary Hyperparathyroidism Undergoing Hemodialysis

Figures & data

Table 1 Patient Baseline Characteristics by Dialysate Calcium Level

Parameter	Evocalcet (n=253)			p-value*	Cinacalcet (n=266)			p-value*
	Dialysate Calcium Level				Dialysate Calcium Level
	2.5 mEq/L	2.75 mEq/L	3.0 mEq/L		2.5 mEq/L	2.75 mEq/L	3.0 mEq/L
	n=71	n=86	n=96		n=70	n=92	n=104
Female, n (%)	18 (25.4)	24 (27.9)	34 (35.4)	0.3247	19 (27.1)	16 (17.4)	36 (34.6)	0.0245
Age, mean (SD), years	62.2 (11.1)	61.1 (11.1)	59.9 (11.8)	0.4264	61.2 (9.3)	60.2 (11.2)	60.8 (12.1)	0.8386
Body mass index, mean (SD), kg/m^2	24.43 (3.88)	24.75 (4.46)	24.53 (5.12)	0.8969	23.45 (3.34)	24.57 (4.80)	23.63 (4.20)	0.1695
Primary disease, n (%)
Diabetic nephropathy	19 (26.8)	23 (26.7)	24 (25.0)	0.8283	14 (20.0)	22 (23.9)	27 (26.0)	0.6337
Chronic glomerulonephritis	24 (33.8)	37 (43.0)	43 (44.8)		28 (40.0)	34 (37.0)	47 (45.2)
Nephrosclerosis	11 (15.5)	9 (10.5)	11 (11.5)		9 (12.9)	12 (13.0)	7 (6.7)
Other	17 (23.9)	17 (19.8)	18 (18.8)		19 (27.1)	24 (26.1)	23 (22.1)
Duration of dialysis, mean (SD), months	126.3 (81.7)	126.2 (85.0)	126.9 (91.2)	0.9980	160.1 (91.7)	135.9 (121.6)	151.8 (103.3)	0.3382
Dry weight, mean (SD), kg	61.83 (12.17)	62.72 (13.81)	62.07 (15.23)	0.9155	60.08 (11.33)	63.66 (15.61)	59.17 (14.36)	0.0720
Dialysis efficiency, mean (SD), spKt/V	1.507 (0.290)	1.495 (0.279)	1.488 (0.293)	0.9121	1.592 (0.293)	1.492 (0.305)	1.544 (0.332)	0.1288
Cinacalcet use (prior to screening), n (%)	47 (66.2)	54 (62.8)	54 (56.3)	0.4006	54 (77.1)	54 (58.7)	71 (68.3)	0.0445
VDRA use at baseline, n (%)	62 (87.3)	74 (86.0)	81 (84.4)	0.8611	68 (97.1)	84 (91.3)	85 (81.7)	0.0042
Oral only	18 (25.4)	29 (33.7)	34 (35.4)	0.2616	16 (22.9)	38 (41.3)	37 (35.6)	0.0113
Parenteral	44 (62.0)	45 (52.3)	47 (49.0)		52 (74.3)	46 (50.0)	48 (46.2)
Laboratory data (baseline), mean (SD)
Intact PTH, pg/mL	408.8 (143.8)	411.0 (197.3)	431.8 (180.7)	0.4929	395.5 (137.4)	438.5 (232.9)	437.5 (191.8)	0.6622
Corrected calcium, mg/dL	9.5 (0.6)	9.5 (0.5)	9.5 (0.6)	0.8901	9.6 (0.5)	9.6 (0.6)	9.6 (0.7)	0.7531
Phosphate, mg/dL	5.82 (1.41)	5.54 (1.24)	5.89 (1.28)	0.1647	5.57 (1.05)	5.50 (1.22)	5.56 (1.09)	0.8950
BAP, µg/L	18.50 (9.42)	17.87 (12.55)	16.64 (7.22)	0.1546	17.07 (5.89)	16.79 (10.16)	18.11 (11.63)	0.3495
TRACP-5b, mU/dL	812.35 (369.07)	759.45 (374.98)	782.85 (430.76)	0.3807	917.90 (427.99)	819.57 (348.06)	854.97 (490.99)	0.3374
FGF23, pg/mL	19,386.18 (21,356.01)	20,761.41 (21,101.79)	23,159.40 (22,139.88)	0.3123	19,488.39 (22,153.09)	19,767.96 (20,321.43)	19,180.45 (19,687.39)	0.7452

Notes: *Chi-square test (categorical), Kruskal–Wallis test, or analysis of variance (continuous).

Abbreviations: BAP, bone alkaline phosphatase; FGF23, fibroblast growth factor 23; PTH, parathyroid hormone; SD, standard deviation; TRACP-5b, tartrate-resistant acid phosphatase 5b; VDRA, vitamin D receptor activator.

Figure 1 Trends in mean intact PTH level (A) and mean percent change in intact PTH level (B) by dialysate calcium concentration in patients treated with evocalcet and cinacalcet.

Abbreviation: PTH, parathyroid hormone.

Figure 2 Trends in mean serum corrected calcium (A) and phosphate (B) level by dialysate calcium concentration in patients treated with evocalcet and cinacalcet.

Figure 3 Incidence of hypocalcemia- (A) and upper gastrointestinal tract-related (B) adverse drug reactions by dialysate calcium concentration in patients treated with evocalcet and cinacalcet. Chi-square test.