The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease

Pórtoles, José; Górriz, José Luis; González, Eduardo Rubio; Álvaro, Fernando de; García, Florencio; Alvarez-Chivas, Vicente; Aranda, Pedro J.; Martínez‐Castelao, Alberto

doi:10.1186/1471-2369-14-2

Cited by 75 publications

(53 citation statements)

References 22 publications

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“…In addition, increased severity of anemia is an independent risk factor for mortality [3]. Reduced erythropoietin (EPO) synthesis in the kidneys is a major contributor to anemia associated with CKD [4].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy and Safety of Molidustat for Anemia in Chronic Kidney Disease: DIALOGUE Extension Studies

et al. 2019

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Background: Molidustat, a novel hypoxia-inducible factor-prolyl hydroxylase inhibitor, is being investigated for the treatment of anemia associated with chronic kidney disease (CKD). The efficacy and safety of molidustat were recently evaluated in three 16-week phase 2b studies. Here, we report the results of two long-term extension studies of molidustat. Methods: Both studies were parallel-group, open-label, multicenter studies of ≤36 months’ duration, in patients with anemia due to CKD, and included an erythropoiesis-stimulating agent as active control. One study enrolled patients not receiving dialysis (n = 164), and the other enrolled patients receiving hemodialysis (n = 88). The primary efficacy variable for both studies was change in blood hemoglobin (Hb) level from baseline to each post-baseline visit, and safety outcomes included adverse events (AEs). Results: In patients not on dialysis, the mean ± SD Hb concentrations at baseline were 11.28 ± 0.55 g/dL for molidustat and 11.08 ± 0.51 g/dL for darbepoetin. The mean ± SD blood Hb concentrations throughout the study (defined as mean of each patient’s overall study Hb levels) were 11.10 ± 0.508 and 10.98 ± 0.571 g/dL in patients treated with molidustat and darbepoetin, respectively. Similar proportions of patients reported at least one AE in the molidustat (85.6%) and darbepoetin (85.7%) groups. In patients on dialysis, mean ± SD Hb levels at baseline were 10.40 ± 0.70 and 10.52 ± 0.53 g/dL in the molidustat and epoetin groups, respectively. The mean ± SD blood Hb concentrations during the study were 10.37 ± 0.56 g/dL in the molidustat group and 10.52 ± 0.47 g/dL in the epoetin group. Proportions of patients who reported at least one AE were 91.2% in the molidustat group and 93.3% in the epoetin group. Conclusions: Molidustat was well tolerated for up to 36 months and appears to be an effective alternative to darbepoetin and epoetin in the long-term management of anemia associated with CKD.

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Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy and Safety of Molidustat for Anemia in Chronic Kidney Disease: DIALOGUE Extension Studies

et al. 2019

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“…Untreated anemia can also accelerate the decline in renal function by causing renal hemodynamic alterations and tissue hypoxia (Portolés et al 2013; Iseki and Kohagura 2007). Patients with CKD and anemia often experience symptoms such as weakness, shortness of breath, and are at increased risk of cardiovascular diseases (CVD) and complications such as left ventricular hypertrophy (National Kidney Foundation 2006).…”

Section: Introductionmentioning

confidence: 99%

Predictors of anemia in a multi-ethnic chronic kidney disease population: a case–control study

et al. 2015

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Anemia is a common complication of chronic kidney disease (CKD). However, risk factors of anemia in CKD patients in Singapore are not well established. Hence, a retrospective, case–control study involving non-dialysis CKD patients was conducted to determine possible predictors of anemia in the local CKD population.Non-dialysis adult CKD patients, not receiving renal replacement therapy or erythropoiesis-stimulating-agents were included. Parameters collected included demographics e.g. age, sex and race; clinical data e.g. CKD stage and medical/medication histories; and laboratory data e.g. serum electrolytes, urinary and hematologic parameters. Patients were classified as anemic or non-anemic using a threshold hemoglobin level of 10 g/dL. The parameters were evaluated for their predictive value for anemia development using multivariate logistical regression and calculation of odds ratios. Statistical analyses were performed using STATA.A total of 457 patients (162 anemic and 295 non-anemic) were analysed. Multivariate analysis showed that probability of developing anemia was greater for patients with stage 5 CKD (OR 16.76, p < 0.001), with hematological disorders (OR 18.61, p < 0.001) and with respiratory disorders (OR 4.54, p = 0.004). The probability of developing anemia was lower for patients with higher previous hemoglobin concentration (OR 0.32, p < 0.001) and in those receiving iron supplements (OR 0.44, p = 0.031). Gender and race were not found to be significant predictors of anemia.Risk of anemia is increased in patients with advanced CKD, haematological disorders, respiratory disorders, and those not taking iron supplements. This study has increased our understanding of the patient subgroups at risk for anemia.

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“…Anemia is common in patients with chronic kidney disease (CKD); severe anemia can reduce quality of life, and increase the risk of cardiovascular (CV) events and mortality [1, 2]. Anemia management is central in care for patients with CKD, and treatment with iron and erythropoiesis-stimulating agents (ESAs) is the standard of care for patients on dialysis.…”

Section: Introductionmentioning

confidence: 99%

Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials

Locatelli¹,

Choukroun²,

Truman³

et al. 2016

Adv Ther

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IntroductionErythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney disease population are maintained in specific subgroups.MethodsData from 13 Phase III trials set up with similar design were retrospectively pooled for this analysis. Patients with chronic kidney disease who had previously been receiving epoetin or darbepoetin were switched to continuous erythropoiesis receptor activator once-monthly after a 4- to 8-week screening period. Patients entered a 16-week continuous erythropoiesis receptor activator dose-titration period followed by an 8-week evaluation period. In total, 2060 patients were included in the analysis. Subgroups were defined based on: hemoglobin target range [lower (10.0–12.0 g/dL)/upper (10.5–13.0 g/dL)], gender (female/male), age (<65/≥65), baseline N-terminal pro-B-type natriuretic peptide levels (<5000/≥5000), cardiovascular risk factors (diabetes/cardiac/vascular/none).ResultsAcross all subgroups analyzed, switching from shorter-acting erythropoiesis-stimulating agents to continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low number of dose changes. The safety profile across subgroups was as expected based on pre-existing risk factors; observed increases in adverse events were attributable to underlying risk factors rather than study drug.ConclusionsThis retrospective analysis of 13 trials showed that continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin levels across a number of clinically relevant patient subgroups, including those with higher inherent cardiovascular risk. The safety profile was consistent with that previously established in the chronic kidney disease population.ClinicalTrials.gov identifiersNCT00413894/NCT00545571/NCT00517413/NCT00560404/NCT00882713/NCT00550680/NCT00576303/NCT00660023/NCT00717821/NCT00642850/NCT00605293/NCT00661505/NCT00699348.FundingF. Hoffmann-La Roche Ltd, Basel, Switzerland.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0309-6) contains supplementary material, which is available to authorized users.

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The development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney disease

Cited by 75 publications

References 22 publications

Long-Term Efficacy and Safety of Molidustat for Anemia in Chronic Kidney Disease: DIALOGUE Extension Studies

Long-Term Efficacy and Safety of Molidustat for Anemia in Chronic Kidney Disease: DIALOGUE Extension Studies

Predictors of anemia in a multi-ethnic chronic kidney disease population: a case–control study

Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials

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