Skip to main content
. 2025 Feb 25;35(2):129–167. doi: 10.25259/ijn_389_23

Table 14:

Evidence profile for roxadustat as an alternative to ESA for anemia in NDD-CKD patients

Population: Anemia in non-dialysis-dependent chronic kidney disease

Intervention: Roxadustat (any dose)

Comparator: Darbepoetin alpha

Outcome

Time frame

Study results and measurements Absolute effect estimates

Certainty of the evidence

Plain language summary
Darbepoetin alpha Roxadustat (any dose)
Treatment emergent adverse events up to 52 weeks in ESA-conditioned patients

Odds ratio: 1.56

(CI 95% 0.89–2.73)

Based on data from 262 participants in one study

702

per 1000

786

per 1000

Very low

Due to very serious risk of bias, due to serious indirectness, due to very serious imprecision1

We are uncertain whether roxadustat (any dose) increases treatment emergent adverse events up to 52 weeks in ESA-conditioned patients.

Difference: 84 more per 1000

(CI 95% 25 fewer–163 more)

Treatment emergent adverse events up to 108 weeks in ESA-naïve patients

Odds ratio: 0.89

(CI 95% 0.50–1.6)

Based on data from 616 participants in one study

925

per 1000

916

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision2

We are uncertain whether roxadustat (any dose) decreases treatment emergent adverse events up to 108 weeks in ESA-naïve patients.

Difference: 8 fewer per 1000

(CI 95% 65 fewer–27 more)

All-cause mortality up to 52 weeks in ESA-conditioned patients

Odds ratio: 0.33

(CI 95% 0.01–8.19)

Based on data from 262 participants in one study

8

per 1000

2

per 1000

Very low

Due to very serious imprecision, due to serious indirectness3

We are uncertain whether roxadustat (any dose) decreases all-cause mortality up to 52 weeks in ESA-conditioned patients.

Difference: 5 fewer per 1000

(CI 95% 8 fewer–54 more)

All-cause mortality up to 108 weeks in ESA-naïve patients

Odds ratio: 0.87

(CI 95% 0.51–1.47)

Based on data from 616 participants in one study

106

per 1000

93

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision4

We are uncertain whether roxadustat (any dose) decreases all-cause mortality up to 108 weeks in ESA-naïve patients.

Difference: 12 fewer per 1000

(CI 95% 49 fewer–42 more)

Incidence of MACE up to 108 weeks in ESA-naïve patients

Odds ratio: 0.82

(CI 95% 0.51–1.31)

Based on data from 616 participants in one study

140

per 1000

117

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision5

We are uncertain whether roxadustat (any dose) decreases incidence of MACE up to 108 weeks in ESA-naïve patients.

Difference: 22 fewer per 1000

(CI 95% 63 fewer–36 more)

Incidence of MACE plus up to 108 weeks in ESA-naïve patients

Odds ratio: 0.91

(CI 95% 0.6–1.38)

Based on data from 616 participants in one study

181

per 1000

167

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision6

We are uncertain whether roxadustat (any dose) decreases incidence of MACE plus up to 108 weeks in ESA-naïve patients.

Difference: 14 fewer per 1000

(CI 95% 64 fewer–53 more)

Need for iron supplementation (bivalent oral) up to 36 weeks in ESA-naïve patients

Odds ratio: 0.78

(CI 95% 0.57–1.07)

Based on data from 616 participants in one study3

498

per 1000

436

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision7

We are uncertain whether roxadustat (any dose) decreases need for iron supplementation (bivalent oral) up to 36 weeks in ESA-naïve patients.

Difference: 62 fewer per 1000

(CI 95% 137 fewer–17 more)

Need for iron supplementation (IV) up to 36 weeks in ESA-naïve patients

Odds ratio: 0.46

(CI 95% 0.26–0.81)

Based on data from 616 participants in one study

126

per 1000

62

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision8

We are uncertain whether roxadustat (any dose) decreases need for iron supplementation (IV) up to 36 weeks in ESA-naïve patients.

Difference: 64 fewer per 1000

(CI 95% 90 fewer–21 fewer)

Need for iron supplementation (trivalent oral) up to 36 weeks in ESA-naïve patients

Odds ratio: 0.67

(CI 95% 0.49–0.93)

Based on data from 616 participants in one study7

447

per 1000

351

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision9

We are uncertain whether roxadustat (any dose) decreases the need for iron supplementation (trivalent oral) up to 36 weeks in ESA-naïve patients.

Difference: 96 fewer per 1000

(CI 95% 163 fewer–18 fewer)

Need for ESA No studies were found that viewed a need for ESA.
Progression to end-stage kidney disease No studies were found that viewed progression to end-stage kidney disease.
Patients requiring blood transfusion up to 108 weeks

Odds ratio: 1.26

(CI 95% 0.75–2.11)

Based on data from 614 participants in one study

96

per 1000

118

per 1000

Very low

Due to very serious risk of bias, due to serious imprecision10

Roxadustat (any dose) may worsen patients requiring blood transfusion up to 108 weeks.

Difference: 22 more per 1000

(CI 95% 22 fewer–87 more)

Health-related QoL No studies were found that viewed health-related QoL.
Fatigue No studies were found that viewed fatigue.
Change in hemoglobin levels from baseline up to 24 weeks in ESA-conditioned patients Measured by: Scale: High better Based on data from 262 participants in one study

Mean

Mean

Very low

Due to very serious risk of bias, due to serious indirectness, due to very serious imprecision11

Roxadustat (any dose) may have little or no difference on hemoglobin levels from baseline up to 24 weeks in ESA-conditioned patients.
Difference: MD 0.12 lower (CI 95% 0.30 lower–0.06 lower)

Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Indirectness: serious. The included study was from only one non-South Asian country and was downgraded for lack of directness by one level; Imprecision: very serious. Wide confidence intervals, low number of patients, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Wide confidence intervals, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Indirectness: serious. The included study was from only one non-South-Asian country and was downgraded for lack of directness by one level; Imprecision: very serious. Wide confidence intervals, low number of patients, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Only data from one study, wide confidence intervals; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Wide confidence intervals, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Wide confidence intervals, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Wide confidence intervals, only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Only data from one study; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Imprecision: serious. Only data from one study, wide confidence intervals; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, incomplete data and/or large loss to follow-up, selective outcome reporting, missing intention-to-treat analysis; Indirectness: serious. The included study was from only one non-South Asian country and was downgraded for lack of directness by one level; Imprecision: very serious. Only data from one study, low number of patients; Publication bias: not serious. Mostly commercially funded studies. ESA: Eythropoiesis-stimulating agents, NDD: Nondialysis dependent, CKD: Chronic kidney disease, MACE: Major adverse cardiovascular events, CI: Confidence interval, QoL: Quality of life, MD: Mean difference.