An Open-Label, Randomized, Multicenter, Controlled Study of Epoetin Alfa for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting

Patel, Meenakshi; Thimons, David G.; Winston, Jaron; Langholff, Wayne; McGowan, Tracy

doi:10.1016/j.jamda.2010.09.009

Cited by 12 publications

(4 citation statements)

References 15 publications

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“…In addition, the long-term safety profile of molidustat observed in both extension studies was consistent with the parent short-term studies, and the pro- files of darbepoetin and epoetin were consistent with previously published data [16][17][18]. The incidences of serious AEs were similar in the molidustat and darbepoetin groups in D3, whereas, in D5, a higher proportion of patients reported at least one serious AE in the molidustat group than in the epoetin group.…”

Section: Discussion/conclusionsupporting

confidence: 88%

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: Discussion/conclusionsupporting

confidence: 88%

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

et al. 2019

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“…In nursing home older adults, ESA can be given infrequently (i.e. every 2–4 weeks) while maintaining an optimal Hb level 37 . A previous report had suggested that a hemoglobin level of 10–11 g/dL is optimal and improved cardiac function, survival and the quality of life 38 .…”

Section: Discussionmentioning

confidence: 99%

Prevalence of anemia in Chinese nursing home older adults: Implication of age and renal impairment

Chan

Yap

Shea

et al. 2012

Geriatrics Gerontology Int

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“…A literature review found that unilateral urethral obstruction models have been used in the majority of studies on renal interstitial fibrosis and conclusions have been recognized generally (6). This is sufficient to confirm that this model is stable and has widespread approval from scholars (7).…”

Section: Introductionmentioning

confidence: 95%

Demethylzeylasteral ameliorates inflammation in a rat model of unilateral ureteral obstruction through inhibiting activation of the NF-κB pathway

Wang

Xiao²,

Liu³

et al. 2017

Molecular Medicine Reports

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The present study investigated the pharmacodynamic role and therapeutic mechanism of demethylzeylasteral in the suppression of inflammation in a rat model of unilateral ureteral obstruction and reduction in nuclear factor (NF)‑κB pathway activity. The rats in the unilateral ureteral obstruction model were treated with 30‑120 mg/kg demethylzeylasteral for 8 weeks. The activities of tumor necrosis factor (TNF)‑α, interleukin (IL)‑6 and caspase‑3/9, and the protein expression levels of cyclooxygenase (COX)‑2 and intercellular adhesion molecule‑1 (ICAM‑1) and NF‑κB p65 were analyzed using ELISA kits and western blot analyses, respectively. Compared with the rats in the unilateral ureteral obstruction model group, demethylzeylasteral treatment markedly inhibited the increased concentrations of serum creatinine and blood urea nitrogen, urinary protein/creatinine ratio, and concentrations of high‑density lipoprotein and low‑density lipoprotein cholesterol, and prevented kidney damage. In addition, demethylzeylasteral inhibited the levels of TNF‑α andIL‑6 and suppressed the protein expression levels of COX‑2 and ICAM‑1 in the kidneys of the rats in the unilateral ureteral obstruction model. Demethylzeylasteral also significantly suppressed the protein expression of NF‑κB p65. The results of the present study suggested that demethylzeylasteral unilateral ureteral obstruction and inhibited inflammation via inhibiting the activation of COX‑2, ICAM‑1 and NF‑κB p65, and suppressing the activities of caspase‑3/9 in rats with unilateral ureteral obstruction.

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An Open-Label, Randomized, Multicenter, Controlled Study of Epoetin Alfa for the Treatment of Anemia of Chronic Kidney Disease in the Long Term Care Setting

Cited by 12 publications

References 15 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

Prevalence of anemia in Chinese nursing home older adults: Implication of age and renal impairment

Demethylzeylasteral ameliorates inflammation in a rat model of unilateral ureteral obstruction through inhibiting activation of the NF-κB pathway

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