Table 2 Open in new tab Hepcidin change...

Study

CKD phase

Molecule

Dose

Mean hepcidin change from baseline (PHD-I)

Control therapy

Mean hepcidin change from baseline (ESA)

P-value

Besarab et al. [11]

Roxadustat

1.5 mg/kg BIW and TIW
2 mg/kg BIW and TIW

−150 ± 89.5 ng/mL
−225 ± 192 ng/mL

Placebo

−17.8 ± 114 ng/mL

0.0013

Provenzano et al. [12]

Roxadustat

1–2 mg/kg TIW or 1.0–2.0 mg/kg TIW or tiered weight based

−60.4 ± 187.8 ng/mL^a

Epoetin alfa

35.6 ± 123.4 ng/mL^a

0.04

Provenzano et al. [28]

Roxadustat

Varying starting doses and frequencies

27.7 (±107.2) ng/mL

None

<0.001^b

Chen et al. [29]

Roxadustat

1.1–1.75 mg/kg and 1.50–2.25 mg/kg TIW

−37.5

Placebo

−4.8 ng/mL

<0.0001

Chen et al. [29]

Roxadustat

1.1–1.8 mg/kg TIW
1.5–2.3 mg/kg TIW
1.7–2.3 mg/kg TIW

−25.7
−86.0
−102.7 ng/mL

Epoetin alfa

−77.9 ng/mL

0.005^c

Holdstock et al. [13]

Daprodustat

5 mg/day

−143.6 mg/L

Placebo

−7.3 mg/L

Holdstock et al. [13]

Daprodustat

5 mg/day

−0.7 mg/L

rHuEPO

−41 mg/L

Akizawa et al. [14]

Daprodustat

4 mg/day
6 mg/day
10 mg/day

−60.4 mg/L^d
−69 mg/L^d
−76.2 mg/L^d

Placebo

3.1 mg/L^d

Cizman et al. [15]

Daprodustat

12 mg/day

−14.5% at week 4
+6.4% at week 20

None

–

Martin et al. [17]

Vadadustat

370, 500, 630 mg/day

−90–139 ng/mL

Placebo

<0.05

Haase et al. [30]

Vadadustat

300 mg QD
450 mg QD
450 mg TIW

−15.1 ± 46.5 ng/mL
−21.7 ± 45.4 ng/mL
−4.9 ± 50.4 ng/dL

None

–

Table 2

Open in new tab

Hepcidin change following therapy with PHD-I in Phase II studies

Study	CKD phase	Molecule	Dose	Mean hepcidin change from baseline (PHD-I)	Control therapy	Mean hepcidin change from baseline (ESA)	P-value
Besarab et al. [11]	ND	Roxadustat	1.5 mg/kg BIW and TIW 2 mg/kg BIW and TIW	−150 ± 89.5 ng/mL −225 ± 192 ng/mL	Placebo	−17.8 ± 114 ng/mL	0.0013
Provenzano et al. [12]	HD	Roxadustat	1–2 mg/kg TIW or 1.0–2.0 mg/kg TIW or tiered weight based	−60.4 ± 187.8 ng/mL^a	Epoetin alfa	35.6 ± 123.4 ng/mL^a	0.04
Provenzano et al. [28]	ND	Roxadustat	Varying starting doses and frequencies	27.7 (±107.2) ng/mL	None	NA	<0.001^b
Chen et al. [29]	ND	Roxadustat	1.1–1.75 mg/kg and 1.50–2.25 mg/kg TIW	−37.5	Placebo	−4.8 ng/mL	<0.0001
Chen et al. [29]	HD	Roxadustat	1.1–1.8 mg/kg TIW 1.5–2.3 mg/kg TIW 1.7–2.3 mg/kg TIW	−25.7 −86.0 −102.7 ng/mL	Epoetin alfa	−77.9 ng/mL	0.005^c
Holdstock et al. [13]	ND	Daprodustat	5 mg/day	−143.6 mg/L	Placebo	−7.3 mg/L	NA
Holdstock et al. [13]	HD	Daprodustat	5 mg/day	−0.7 mg/L	rHuEPO	−41 mg/L	NA
Akizawa et al. [14]	HD	Daprodustat	4 mg/day 6 mg/day 10 mg/day	−60.4 mg/L^d −69 mg/L^d −76.2 mg/L^d	Placebo	0	3.1 mg/L^d
Cizman et al. [15]	HD	Daprodustat	12 mg/day	−14.5% at week 4 +6.4% at week 20	None	–	–
Martin et al. [17]	ND	Vadadustat	370, 500, 630 mg/day	−90–139 ng/mL	Placebo	NA	<0.05
Haase et al. [30]	HD	Vadadustat	300 mg QD 450 mg QD 450 mg TIW	−15.1 ± 46.5 ng/mL −21.7 ± 45.4 ng/mL −4.9 ± 50.4 ng/dL	None	–	–

Study	CKD phase	Molecule	Dose	Mean hepcidin change from baseline (PHD-I)	Control therapy	Mean hepcidin change from baseline (ESA)	P-value
Besarab et al. [11]	ND	Roxadustat	1.5 mg/kg BIW and TIW 2 mg/kg BIW and TIW	−150 ± 89.5 ng/mL −225 ± 192 ng/mL	Placebo	−17.8 ± 114 ng/mL	0.0013
Provenzano et al. [12]	HD	Roxadustat	1–2 mg/kg TIW or 1.0–2.0 mg/kg TIW or tiered weight based	−60.4 ± 187.8 ng/mL^a	Epoetin alfa	35.6 ± 123.4 ng/mL^a	0.04
Provenzano et al. [28]	ND	Roxadustat	Varying starting doses and frequencies	27.7 (±107.2) ng/mL	None	NA	<0.001^b
Chen et al. [29]	ND	Roxadustat	1.1–1.75 mg/kg and 1.50–2.25 mg/kg TIW	−37.5	Placebo	−4.8 ng/mL	<0.0001
Chen et al. [29]	HD	Roxadustat	1.1–1.8 mg/kg TIW 1.5–2.3 mg/kg TIW 1.7–2.3 mg/kg TIW	−25.7 −86.0 −102.7 ng/mL	Epoetin alfa	−77.9 ng/mL	0.005^c
Holdstock et al. [13]	ND	Daprodustat	5 mg/day	−143.6 mg/L	Placebo	−7.3 mg/L	NA
Holdstock et al. [13]	HD	Daprodustat	5 mg/day	−0.7 mg/L	rHuEPO	−41 mg/L	NA
Akizawa et al. [14]	HD	Daprodustat	4 mg/day 6 mg/day 10 mg/day	−60.4 mg/L^d −69 mg/L^d −76.2 mg/L^d	Placebo	0	3.1 mg/L^d
Cizman et al. [15]	HD	Daprodustat	12 mg/day	−14.5% at week 4 +6.4% at week 20	None	–	–
Martin et al. [17]	ND	Vadadustat	370, 500, 630 mg/day	−90–139 ng/mL	Placebo	NA	<0.05
Haase et al. [30]	HD	Vadadustat	300 mg QD 450 mg QD 450 mg TIW	−15.1 ± 46.5 ng/mL −21.7 ± 45.4 ng/mL −4.9 ± 50.4 ng/dL	None	–	–

At Week 19.

Versus baseline.

Versus high dose.

Median.

TIW, thrice weekly; BIW, twice weekly; QD, four times per week; rHuEPO, recombinant human EPO.

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