Clinical Practice Guideline for the Management of Chronic Kidney Disease‐Mineral and Bone Disorder

Fukagawa, Masafumi; Yokoyama, Keitaro; Koiwa, Fumihiko; Taniguchi, Masatomo; Shoji, Tetsuo; Kazama, Junichiro James; Komaba, Hirotaka; Ando, Ryoichi; Kakuta, Tsunekazu; Fujii, Hideki; Nakayama, Msasaaki; Shibagaki, Yugo; Fukumoto, Seiji; Fujii, Naohiko; Hattori, Motoshi; Ashida, Akira; Iseki, Kunitoshi; Sügimura, Takashi; Tsukamoto, Yusuke; Tsubakihara, Yoshiharu; Tomo, Tadashi; Hirakata, Hideki; Akizawa, Tadao

doi:10.1111/1744-9987.12058

Cited by 335 publications

(349 citation statements)

References 372 publications

(575 reference statements)

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“…Along this line is also the high proportion of medical directors in the current DOPPS phase (24.1% in Eur-A/NZ and 42.9% in North America) who target an upper limit of PTH$600 pg/ml, exceeding the current KDIGO target, which was on the basis of a low level of evidence (16). Consistent with local guidelines (35,36) in Japan, reported PTH targets declined through DOPPS 4 and increased slightly in DOPPS 5.…”

Section: Discussionsupporting

confidence: 74%

Recent Changes in Therapeutic Approaches and Association with Outcomes among Patients with Secondary Hyperparathyroidism on Chronic Hemodialysis

Tentori

Mia

Bieber

et al. 2015

Clinical Journal of the American Society of Nephrology

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253

236

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Background and objectives Elevated parathyroid hormone levels may be associated with adverse clinical outcomes in patients on dialysis. After the introduction of practice guidelines suggesting higher parathyroid hormone targets than those previously recommended, changes in parathyroid hormone levels and treatment regimens over time have not been well documented.Design, setting, participants, & measurements Using data from the international Dialysis Outcomes and Practice Patterns Study, trends in parathyroid hormone levels and secondary hyperparathyroidism therapies over the past 15 years and the associations between parathyroid hormone and clinical outcomes are reported; 35,655 participants from the Dialysis Outcomes and Practice Patterns Study phases 1-4 (1996-2011) were included.Results Median parathyroid hormone increased from phase 1 to phase 4 in all regions except for Japan, where it remained stable. Prescriptions of intravenous vitamin D analogs and cinacalcet increased and parathyroidectomy rates decreased in all regions over time. Compared with 150-300 pg/ml, in adjusted models, all-cause mortality risk was higher for parathyroid hormone=301-450 (hazard ratio, 1.09; 95% confidence interval, 1.01 to 1.18) and .600 pg/ml (hazard ratio, 1.23; 95% confidence interval, 1.12 to 1.34). Parathyroid hormone .600 pg/ml was also associated with higher risk of cardiovascular mortality as well as all-cause and cardiovascular hospitalizations. In a subgroup analysis of 5387 patients not receiving vitamin D analogs or cinacalcet and with no prior parathyroidectomy, very low parathyroid hormone (,50 pg/ml) was associated with mortality (hazard ratio, 1.25; 95% confidence interval, 1.04 to 1.51). ConclusionsIn a large international sample of patients on hemodialysis, parathyroid hormone levels increased in most countries, and secondary hyperparathyroidism treatments changed over time. Very low and very high parathyroid hormone levels were associated with adverse outcomes. In the absence of definitive evidence in support of a specific parathyroid hormone target, there is an urgent need for additional research to inform clinical practice.

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Section: Discussionsupporting

confidence: 74%

Recent Changes in Therapeutic Approaches and Association with Outcomes among Patients with Secondary Hyperparathyroidism on Chronic Hemodialysis

Tentori

Mia

Bieber

et al. 2015

Clinical Journal of the American Society of Nephrology

Self Cite

253

236

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“…As for serum calcium levels, although it is not clear whether low levels are detrimental, high levels are known to be associated with a poor prognosis [3,4,8]. Given these background conditions, each guideline provides target values for serum phosphorus and calcium levels when managing patients on dialysis [1,9].…”

Section: Introductionmentioning

confidence: 99%

Relationship between serum calcium level at dialysis initiation and subsequent prognosis

et al. 2017

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Background: In patients on maintenance dialysis, increased serum calcium levels are known to be associated with a poor prognosis. However, it is not known whether serum calcium levels at dialysis initiation have an impact on subsequent prognosis. Methods: The subjects were patients who were newly initiated dialysis at the 17 Aichi Cohort Study of Prognosis in Patients Newly Initiated into Dialysis (AICOPP) group centers. The study included 1524 patients who were at least 20 years old, had CKD, and provided written consent. We excluded one patient whose serum adjusted calcium was not assessed and six patients whose outcomes were unknown. Thus, we enrolled 1517 subjects into the study. The patients were divided into the following five groups: (1) G1 with a serum adjusted calcium level <7.0 mg/dL, (2) G2 with 7.0 to <8.0 mg/dL, (3) G3 with 8.0 to <9.0 mg/dL, (4) G4 with 9.0 to <10.0 mg/dL, and (5) G5 with ≥10.0 mg/dL. The study outcomes included: (1) comparisons of all-cause mortality rates in the five groups; (2) extraction of factors influencing all-cause mortality. Results: There were 268 deaths during the follow-up period (G1, 9 cases; G2, 30 cases; G3, 91 cases; G4, 110 cases; G5, 28 cases). Significant differences were observed between the five groups' cumulative survival rates (Logrank test p = 0.005) by using Kaplan-Meier method. There were significant differences in the incidence of either aortic or cardiac valve calcification among the five groups (aortic calcification: p = 0.006, cardiac valve calcification: p = 0.008). Moreover, lower Barthel Index, which evaluated activities of daily living, were associated with higher serum adjusted calcium levels (p < 0.001). Multivariate Cox proportional hazard analysis using the stepwise method indicated that increasing serum adjusted calcium was associated with all-cause mortality (every 1 mg/dL increase, HR = 1.267, 95% CI = 1.092 − 1.470, p = 0.002). In addition, high mortality was associated with advanced age, male gender, low systolic blood pressure, history of cardiovascular disease, and no prior use of calcium carbonate. Conclusions: Serum adjusted calcium levels at dialysis initiation were demonstrated to be associated with all-cause mortality after dialysis initiation.

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“…In patients with CKD, elevated serum phosphate is associated with vascular calcification (7,8), progression of CKD, and increased mortality (4,(9)(10)(11)(12). Consequently, the Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) (13) and the Japanese Society for Dialysis Therapy (14) recommend maintaining serum phosphate of CKD patients within the normal range.…”

Section: Introductionmentioning

confidence: 99%

Ferric Citrate Hydrate for the Treatment of Hyperphosphatemia in Nondialysis-Dependent CKD

Yokoyama

Hirakata

Akiba

et al. 2014

Clinical Journal of the American Society of Nephrology

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109

124

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Background and objectives Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD.Design, setting, participants, & measurements A phase 3, multicenter, randomized, double blind, placebocontrolled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD. Starting in April of 2011, 90 CKD patients (eGFR=9.2165.72 ml/min per 1.73 m 2 ) with a serum phosphate$5.0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks. The primary end point was change in serum phosphate from baseline to the end of treatment. Secondary end points included the percentage of patients achieving target serum phosphate levels (2.5-4.5 mg/dl) and change in fibroblast growth factor-23 at the end of treatment.Results The mean change in serum phosphate was 21.29 mg/dl (95% confidence interval, 21.63 to 20.96 mg/dl) in the ferric citrate hydrate group and 0.06 mg/dl (95% confidence interval, 20.20 to 0.31 mg/dl) in the placebo group (P,0.001 for difference between groups). The percentage of patients achieving target serum phosphate levels was 64.9% in the ferric citrate hydrate group and 6.9% in the placebo group (P,0.001). Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo (change from baseline [median], 2142.0 versus 67.0 pg/ml; P,0.001). Ferric citrate hydrate significantly increased serum iron, ferritin, and transferrin saturation compared with placebo (P=0.001 or P,0.001). Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo. Overall, adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo, with gastrointestinal disorders occurring in 30.0% of ferric citrate hydrate patients and 26.7% of patients receiving placebo. ConclusionIn patients with nondialysis-dependent CKD, 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters.

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Clinical Practice Guideline for the Management of Chronic Kidney Disease‐Mineral and Bone Disorder

Cited by 335 publications

References 372 publications

Recent Changes in Therapeutic Approaches and Association with Outcomes among Patients with Secondary Hyperparathyroidism on Chronic Hemodialysis

Recent Changes in Therapeutic Approaches and Association with Outcomes among Patients with Secondary Hyperparathyroidism on Chronic Hemodialysis

Relationship between serum calcium level at dialysis initiation and subsequent prognosis

Ferric Citrate Hydrate for the Treatment of Hyperphosphatemia in Nondialysis-Dependent CKD

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