Table 2:
Evidence profile for desidustat as an alternative to ESA for anemia in NDD-CKD patients
Population: Anemia in non-dialysis-dependent chronic kidney disease Intervention: Desidustat (any dose) Comparator: Darbepoetin alpha | |||||
Outcome Time frame |
Study results and measurements | Absolute effect estimates |
Certainty of tde Evidence (Quality of evidence) |
Plain language summary | |
Darbepoetin alpha | Desidustat (any dose) | ||||
Any adverse events up to 26 weeks in ESA-naïve patients |
Odds ratio: 0.91 (CI 95% 0.66–1.26) Based on data from 588 participants in one study |
503 per 1000 |
479 per 1000 |
Low Due to serious risk of bias, due to serious imprecision1 |
We are uncertain whether desidustat (any dose) decreases adverse events up to 26 weeks in ESA-naïve patients. |
Difference: 24 fewer per 1000 (CI 95% 103 fewer–301 fewer) | |||||
All-cause mortality up to 26 weeks in ESA-naïve patients |
Odds ratio: 1.0 (CI 95% 0.32–3.14) Based on data from 588 participants in one study |
20 per 1000 |
20 per 1000 |
Low Due to serious risk of bias, due to serious imprecision2 |
We are uncertain whether compared to conventional ESA, desidustat has no difference in all-cause mortality up to 26 weeks in ESA-naïve patients. |
Difference: 0 fewer per 1000 (CI 95% 14 fewer–40 more) | |||||
Incidences of MACE and MACE plus | No studies were found that viewed incidences of MACE and MACE plus. | ||||
Progression to end-stage kidney disease | No studies were found that viewed progression to end-stage kidney disease. | ||||
Need for iron supplement | No studies were found that viewed the need for iron supplementation. | ||||
Patient requiring blood transfusion | No studies were found that viewed a patient requiring blood transfusion. | ||||
Change in hemoglobin levels from baseline up to 24 weeks in ESA-naïve patients |
Measured by: Scale: High better Based on data from 529 participants in one study |
Mean |
Mean |
Low Due to serious risk of bias, due to serious imprecision3 |
Desidustat (any dose) probably has little or no difference on change in hemoglobin levels from baseline compared to ESA up to 24 weeks in ESA-naïve patients. |
Difference: MD 0.09 lower (CI 95% 0.15 lower–0.33 lower) | |||||
QoL (SF 36 score) at 24 weeks in ESA-naïve patients |
Measured by: Scale: High better Based on data from 480 participants in one study |
Mean | Mean |
Low Due to serious risk of bias, due to serious imprecision4 |
Desidustat may have little or no difference on QoL (SF 36 score) at 24 weeks in ESA-naïve patients. |
Difference: MD 0.00 lower (CI 95% 98.20 lower–98.20 lower) | |||||
Fatigue | No studies were found that viewed fatigue. | ||||
Need for ESA up to 24 weeks in ESA-naïve patients | Based on data from 588 participants in one study |
Low Due to serious risk of bias, due to serious imprecision5 |
There were too few ESA-naïve patients who experienced the need for ESA up to 24 weeks to determine whether desidustat (any dose) made a difference. |
Risk of Bias: serious. Missing intention-to-treat analysis, inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias; Imprecision: serious. Wide confidence intervals, only data from one study, inadequate optimal information size (OIS); The 95% CI of the included study overlaps line of no effect (i.e., CI includes 1.0) rate. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, missing intention-to-treat analysis; Imprecision: serious. Wide confidence intervals, only data from one study, inadequate optimal information size (OIS); Publication bias: not serious. Study is commercially funded. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, missing intention-to-treat analysis; Imprecision: serious. Only data from one study, inadequate optimal information size (OIS); Publication bias: not serious. Study is commercially funded. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, missing intention-to-treat analysis; Imprecision: serious. Only data from one study, inadequate optimal information size (OIS); Publication bias: not serious. Study is commercially funded. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, missing intention-to-treat analysis; Imprecision: serious. Low number of patients, only data from one study, inadequate optimal information size (OIS); Publication bias: not serious. Study is commercially funded. ESA: Eythropoiesis-stimulating agents, NDD: Nondialysis dependent, CKD: Chronic kidney disease, MACE: Major adverse cardiovascular events, CI: Confidence interval, SF 36: Short Form 36, MD: Mean difference, QoL: Quality of life.