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

Table 29:

Evidence profile for molidustat as an alternative to ESA for DD-CKD patients

Population: Anemia in dialysis-dependent chronic kidney disease

Intervention: Molidustat

Comparator: ESA (epoetin alpha/epoetin beta/darbepoetin alpha)

Outcome

Time frame

Study results and measurements Absolute effect estimates Certainty of the evidence Plain language summary
ESA (epoetin alpha/epoetin beta/darbepoetin alpha) Molidustat
Need for iron supplementation (oral) up to 52 weeks

Odds ratio: 3.45

(CI 95% 0.99–12.05)

Based on data from 229 participants in one study

39

per 1000

122

per 1000

Very low

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

We are uncertain whether molidustat (any dose) increases the need for iron supplementation (oral) up to 52 weeks.

Difference: 84 more per 1000

(CI 95% 0–289 more)

All-cause mortality up to 52 weeks Odds ratio: 0.56 (CI 95% 0.10–3.04) Based on data from 428 participants in two studies

17

per 1000

9

per 1000

Very low

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

We are uncertain whether molidustat (any dose) decreases all-cause mortality up to 52 weeks.
Difference: 7 fewer per 1000 (CI 95% 15 fewer–33 more)
Need for ESA up to 52 weeks

Odds ratio: 8.15

(CI 95% 1.06–62.93)

Based on data from 229 participants in one study

13

per 1000

96

per 1000

Very low

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

We are uncertain whether molidustat (any dose) increases the need for ESA up to 52 weeks.

Difference: 84 more per 1000

(CI 95% 1 more–440 more)

Need for iron supplementation (IV) up to 52 weeks

Odds ratio: 0.96

(CI 95% 0.54–1.69)

Based on data from 229 participants in one study

632

per 1000

622

per 1000

Very low

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

We are uncertain whether molidustat (any dose) decreases the need for iron supplementation (IV) up to 52 weeks.

Difference: 10 fewer per 1000

(CI 95% 151 fewer–112 more)

Incidences of MACE up to 52 weeks Odds ratio: 1.25 (CI 95% 0.24–6.60) Based on data from 229 participants in one study

26

per 1000

32

per 1000

Very low

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

We are uncertain whether molidustat (any dose) increases incidences of MACE up to 52 weeks.
Difference: 6 more per 1000 (CI 95% 20 fewer–124 more)
Treatment emergent adverse event up to 52 weeks

Odds ratio: 1.24

(CI 95% 0.62–2.45)

Based on data from 428 participants in two studies

881

per 1000

901

per 1000

Very low

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

We are uncertain whether molidustat increases treatment emergent adverse event up to 52 weeks.

Difference: 21 more per 1000

(CI 95% 60 fewer–67 more)

Patients requiring blood transfusion up to 20 weeks

Odds ratio: 1.47

(CI 95% 0.34–6.38)

Based on data from 199 participants in one study

48

per 1000

69

per 1000

Very low

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

We are uncertain whether molidustat (any dose) increases patients requiring blood transfusion up to 20 weeks.

Difference: 21 more per 1000

(CI 95% 31 fewer–195 more)

Change in hemoglobin levels from baseline up to 36 weeks

Measured by:

Scale: High better

Based on data from 379 participants in two studies

Mean

Mean

Low

due to serious risk of bias, due to serious imprecision8

We are uncertain whether molidustat (any dose) lowered the hemoglobin levels from baseline up to 36 weeks.

Difference: 0.17 lower (MD)

(CI 95% 0.43 lower–0.10 higher)

QoL No studies were found that viewed QoL.
Fatigue No studies were found that viewed fatigue.

Risk of Bias: serious. Missing intention-to-treat analysis; Indirectness: serious. The included study was from only one country which is not in South Asia 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, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: serious. Missing intention-to-treat analysis; Imprecision: very serious. Wide confidence intervals, low number of patients, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0). Risk of Bias: serious. Missing intention-to-treat analysis; Indirectness: serious. The included study was from only one country which is not in South Asia and was downgraded for lack of directness by one level; Imprecision: very serious. Only data from one study, low number of patients, wide confidence intervals, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: serious. Missing intention-to-treat analysis; Indirectness: serious. The included study was from only one country which is not in South Asia 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, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0). Risk of Bias: serious. Missing intention-to-treat analysis; Indirectness: serious. The included study was from only one country which is not in South Asia 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, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate; Publication bias: not serious. Mostly commercially funded studies. Risk of Bias: serious. Missing intention-to-treat analysis; Imprecision: very serious. Wide confidence intervals, low number of patients, the 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0). 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; 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: serious. Missing intention-to-treat analysis; Imprecision: serious. Low number of patients, only data from one study; Publication bias: not serious. Mostly commercially funded studies. DD: Dialysis-Dependent, CKD: Chronic kidney disease, ESA: Eythropoiesis-stimulating agents, MACE: Major adverse cardiovascular events, HIF PHI: Hypoxia-inducible factor prolyl hydroxylase inhibitor, CI: Confidence interval, MD: Mean difference, QoL: Quality of life