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

Table 8:

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

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

Intervention: Enarodustat (any dose)

Comparator: Darbepoetin alpha

Outcome

Time frame

Study results and measurements Absolute effect estimates Certainty of the Evidence Plain language summary
Darbepoetin alpha Enarodustat (any dose)
All-cause mortality up to 26 weeks in ESA-naïve and ESA-conditioned patients

Odds ratio: 0.34

(CI 95% 0.01–8.35)

Based on data from 216 participants in one study

9

per 1000

3

per 1000

Very low

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

We are uncertain whether enarodustat (any dose) decreases all-cause mortality up to 26 weeks in ESA-naïve and ESA-conditioned patients.

Difference: 6 fewer per 1000

(CI 95% 9 fewer–61 more)

Adverse events up to 26 weeks in ESA-naïve and ESA-conditioned patients

Odds ratio: 0.40

(CI 95% 0.21–0.75)

Based on data from 216 participants in one study

826

per 1000

655

per 1000

Very low

Due to very serious risk of bias, due to very serious indirectness2

We are uncertain whether enarodustat (any dose) decreases adverse events up to 26 weeks in ESA-naïve and ESA-conditioned patients.

Difference: 171 fewer per 1000

(CI 95% 327 fewer–45 fewer)

Adverse events up to 26 weeks in ESA-naïve patients

Odds ratio: 0.40

(CI 95% 0.15–1.10)

Based on data from 102 participants in one study

865

per 1000

719

per 1000

Very low

Due to very serious risk of bias, due to very serious indirectness, due to very serious imprecision3

We are uncertain whether enarodustat (any dose) decreases adverse events up to 26 weeks in ESA-naïve patients.

Difference: 146 fewer per 1000

(CI 95% 375 fewer–11 more)

Adverse events up to 26 weeks in ESA-conditioned patients

Odds ratio: 0.39

(CI 95% 0.17–0.90)

Based on data from 114 participants in one study

789

per 1000

593

per 1000

Very low

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

We are uncertain whether enarodustat (any dose) decreases adverse events up to 26 weeks in ESA-conditioned patients.

Difference: 196 fewer per 1000

(CI 95% 400 fewer–18 fewer)

Incidences of MACE and MACE plus No studies were found that viewed incidences of MACE and MACE plus.
Need for iron supplementation No studies were found that viewed the need for iron supplementation.
Need for ESA No studies were found that viewed the need for ESA.
Progression to end-stage kidney disease No studies were found that viewed the progression to end-stage kidney disease.
Patients requiring blood transfusio No studies were found that viewed patients requiring blood transfusion.
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 Measured by: Scale: High better Based on data from 193 participants in one study Mean Mean

Very low

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

We are uncertain whether enarodustat (any dose) has little or no difference on change in hemoglobin levels from baseline up to 24 weeks.
Difference: MD 0.09 lower(CI 95% 0.08 lower–0.26 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, missing intention-to-treat analysis; Indirectness: very serious. The included study was from only one country and was downgraded for lack of directness by two levels; Imprecision: very serious. Low number of patients, only data from one study, wide confidence intervals; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: very serious. Missing intention-to-treat analysis, 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; Indirectness: very serious. The included study was from only one country and was downgraded for lack of directness by two levels; 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, missing intention-to-treat analysis; Indirectness: very serious. The included study was from only one country and was downgraded for lack of directness by two levels; Imprecision: very serious. Low number of patients, 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, missing intention-to-treat analysis; Indirectness: very serious. The included study was from only one country and was downgraded for lack of directness by two levels; Imprecision: serious. 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, inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, incomplete data and/or large loss to follow-up, missing intention-to-treat analysis; Indirectness: very serious. The included study was from only one country and was downgraded for lack of directness by two levels; Imprecision: serious. Low number of patients, only data from one study; Publication bias: not serious. Mostly commercially funded studies. ESA: Eythropoiesis-stimulating agents, NDD: Nondialysis dependent, CKD: Chronic kidney disease, CI: Confidence interval, MACE: Major adverse cardiovascular events, QoL: Quality of life.