Table 20:
Evidence profile for desidustat as an alternative to ESA for anemia in DD-CKD patients
Population: Anemia in dialysis-dependent chronic kidney disease Intervention: Desidustat Comparator: Epoetin alfa | |||||
Outcome Time frame |
Study results and measurements | Absolute effect estimates | Certainty of the evidence | Plain language summary | |
Epoetin Alpha | Desidustat | ||||
All-cause mortality up to 26 weeks |
Odds ratio: 0.56 (CI 95% 0.16–1.95) Based on data from 392 participants in one study |
36 per 1000 |
20 per 1000 |
Very low Due to very serious risk of bias, due to very serious imprecision1 |
We are uncertain whether desidustat (any dose) decreases all-cause mortality up to 26 weeks in comparison with ESAs. |
Difference: 16 fewer per 1000 (CI 95% 30 fewer–32 more) | |||||
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. | ||||
Incidences of MACE and MACE plus | No studies were found that viewed incidences of MACE and MACE plus. | ||||
Treatment emergent adverse events up to 26 weeks | Odds ratio: 1.06 (CI 95% 0.72–1.58) Based on data from 392 participants in one study |
464 per 1000 |
478 per 1000 |
Very low Due to very serious risk of bias, due to very serious imprecision2 |
We are uncertain whether desidustat (any dose) increases treatment emergent adverse events up to 26 weeks. |
Difference: 15 more per 1000 (CI 95% 80 fewer–114 more) | |||||
Patients requiring blood transfusion | No studies were found that viewed patients requiring blood transfusion. | ||||
Change in hemoglobin levels from baseline up to 16–24 weeks |
Measured by: Scale: High better Based on data from 373 participants in one study |
Mean | Mean |
Very low Due to very serious risk of bias, due to serious imprecision3 |
Desidustat may have little or no difference compared with ESAs on changes in hemoglobin levels from baseline up to 16–24 weeks. |
Difference: MD 0.07 lower (CI 95% 0.23 lower–0.37 lower) | |||||
Fatigue | No studies were found that viewed fatigue. | ||||
QoL assessed by SF-36 up to 24 weeks | Measured by: SF-36 Scale: High better Based on data from 346 participants in one study | Mean | Mean |
Very low Due to very serious risk of bias, due to serious imprecision4 |
We are uncertain whether desidustat worsens QoL assessed by SF-36 up to 24 weeks. |
Difference: MD 49.73 higher (CI 95% 144.53 higher–45.07 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, missing intention-to-treat analysis; Imprecision: very serious. Wide confidence intervals, only data from one study, low number of patients, 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate; Publication bias: not serious. The study is commercially funded. Risk of Bias: very serious. Inadequate/lack of blinding of outcome assessors, resulting in potential for detection bias, inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, missing intention-to-treat analysis; Imprecision: very serious. Only data from one study, wide confidence intervals, low number of patients, 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate; Publication bias: not serious. The study is commercially funded. 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, missing intention-to-treat analysis; Imprecision: very serious. Low number of patients, only data from one study, and inadequate optimal information size (OIS); Publication bias: not serious. The study is commercially funded. 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, missing intention-to-treat analysis; Imprecision: very serious. Only data from one study, low number of patients, and inadequate optimal information size (OIS); Publication bias: not serious. The study is commercially funded. DD: Dialysis-Dependent, CKD: Chronic kidney disease, ESA: Eythropoiesis-stimulating agents, CI: Confidence interval, MACE: Major adverse cardiovascular events, MD: Mean difference, SF 36: Short Form 36 Health Survey, QoL: Quality of life