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Aim: This study aimed to assess the pharmacokinetics of henagliflozin in dialysis patients with diabetes., Methods: In this prospective, randomized, open-label study where 10 hemodialysis and 10 peritoneal dialysis patients with diabetes were randomized in a 1:1:1:1 ratio to oral administration of henagliflozin in doses of 5 and 10 mg/day. The pharmacokinetics of a single dose of henagliflozin on Days 1 and 2, the minimum plasma concentration (C min ) of the steady state on Day 10, and single hemodialysis clearance of henagliflozin were measured., Results: The mean values of C max were 70.2-77.0 ng/mL and 105-143 ng/mL in the 5 mg and 10 mg henagliflozin groups, respectively; the mean values of AUC inf were 777-811 h*ng/mL and 1290-1730 h*ng/mL in the 5 mg and 10 mg henagliflozin groups, respectively. The median T max values ranged from 1 to 3 h across the dose range. The mean values of T 1/2 of henagliflozin were 14.1-14.5 and 16.2-21.0 h in the 5 mg and 10 mg groups, respectively. The C min values of the steady state in dialysis patients taking 5 mg and 10 mg of henagliflozin were 15.0 ± 4.4 ng/mL and 26.8 ± 16.3 ng/mL, respectively, which were 123.8% and 131.0% higher than those in diabetic patients with normal renal function, respectively. Henagliflozin concentration was decreased by 1.1% after hemodialysis treatment. No treatment-related serious adverse events or discontinuations occurred., Conclusions: Henagliflozin at the current recommended dosage may be safe, although it is possible to result in slight accumulation in patients on dialysis., Registration: Chinese Clinical Trial Registry number ChiCTR2200062872. The date of registration: August 22, 2022., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Twice-weekly hemodialysis (HD) could be regarded as an important part of incremental hemodialysis, volume status of this treatment model remains to be elucidated., Methods: Patients undergoing regular twice-weekly or thrice-weekly hemodialysis in our unit on June 2015 were enrolled into the cohort study with an average of 2.02 years follow-up. Volume status of the subjects was evaluated by clinical characteristics, plasma B-type natriuretic peptide (BNP) levels and bioimpedance assessments with body composition monitor (BCM). Cox proportional hazards models and Kaplan-Meier analysis were used to compare patient survival between the two groups., Results: Compared with patients on thrice-weekly HD, twice-weekly HD patients had significantly higher log-transformed BNP levels (2.54 ± 0.41 vs. 2.33 ± 0.49 pg/ml, p  = 0.010). Overhydration (OH) and the ratio of overhydration to extracellular water (OH/ECW) in twice-weekly HD group were significantly higher than that of thrice-weekly HD (OH, 2.54 ± 1.42 vs. 1.88 ± 1.46, p  = 0.033; OH/ECW, 0.17 ± 0.07 vs. 0.12 ± 0.08, p  = 0.015). However, subgroup analysis of patients within 6 years HD vintage indicated that the two groups had similar hydration status. Multivariate Cox regression analysis showed that log-transformed BNP levels, serum albumin and diabetes status were predictors of mortality in hemodialysis patients. Kaplan-Meier survival analysis indicated that patients with BNP levels higher than 500 pg/ml had significantly worse survival compared with those with lower BNP levels ( p  = 0.014)., Conclusions: Twice-weekly hemodialysis patients had worse volume status than that of thrice-weekly HD patients especially for those with long-term dialysis vintage, BNP level was a powerful predictor of mortality in HD patients.

Objective: This study aimed to explore the effectiveness of thiamin and folic acid supplementation on the improvement of the cognitive function in patients with maintenance hemodialysis., Method: In the present study, we randomly assigned patients undergoing hemodialysis who had the Montreal Cognitive Assessment (MoCA) score lower than 26 to treatment group ( n  = 25, thiamin 90 mg/day combined with folic acid 30 mg/day) or control group ( n  = 25, nonintervention). All subjects were followed up for 96 weeks. The primary outcome was the improvement of the MoCA score. The secondary outcomes included homocysteine level, survival and safety., Results: Patients in treatment group had an increase of the MoCA score from 21.95 ± 3.81 at baseline to 25.68 ± 1.96 at week 96 ( p  < 0.001, primary outcome), as compared with the MoCA score from 20.69 ± 3.40 to 19.62 ± 3.58 in control group. Thiamin combined with folic acid treatment also resulted in lower level of serum homocysteine in treatment group compare with control group at week 96 ( p  < 0.05, secondary outcome). 3 patients and 9 patients died during follow-up period in treatment and control group respectively ( p  = 0.048). The proportion of adverse events in treatment group was significantly lower than that in control group., Conclusion: Hemodialysis patients with cognitive impairment treated with thiamin and folic acid had a significant improvement in MoCA score.

Aim: Vascular calcification has played a vital role in increasing the prevalence of cardiovascular disease (CVD) and mortality in maintenance haemodialysis (MHD) patients. This study is aimed at exploring the prognostic value of abdominal aortic calcification (AAC) estimated by plain lateral abdominal radiography in MHD patients., Methods: Lateral abdominal radiography was used to determine the abdominal aortic calcification score (AACS). The serum level of fibroblast growth factor-23 was tested by enzyme-linked immunosorbent assay. Patients were divided into two groups: no or minor calcification group (AACS < 5) and moderate to severe calcification group (AACS ≥ 5). All patients were followed up to death or the end of the study (30 November 2016)., Results: A total of 114 patients were enrolled in this study, including 64 males (56.1%), and the mean age was 57.42 ± 13.48 years. Seventy-six patients (66.7%) exhibited AAC. Independent predictors for moderate to severe calcification were older age (odds ratio (OR) 1.06 (1.02-1.10), P = 0.003), longer dialysis vintage (OR 1.01 (1.00-1.02), P = 0.039), presence of smoking (OR 3.01 (1.18-7.70), P = 0.021) and higher Log fibroblast growth factor-23 serum levels (OR 2.83 (1.01-7.94), P = 0.048). During a median follow-up of 6.0 (5.6, 6.1) years, 22 patients (19.3%) died of all-cause death, and 17 cases (14.9%) died of CVD. Kaplan-Meier survival curves showed that patients in the moderate to severe calcification group had significantly higher all-cause (28.3 vs 11.5%, P = 0.028) and CVD mortality (22.6 vs 8.2%, P = 0.035) than that in the no or minor calcification group. A multivariate Cox regression showed that AACS (hazard ratio 1.08 (1.01-1.15), P = 0.022) was an independent predictor of CVD mortality. Compared with the no or minor calcification group, the risk of CVD mortality was increased by a factor of 3.14 in patients in the moderate to severe calcification group (hazard ratio 3.14 (1.04-9.44), P = 0.042)., Conclusion: Our data suggest that AAC is prevalent in MHD patients and could provide potential predictive information for CVD mortality. Plain lateral abdominal radiography, which is simple and cheap and involves lower radiation, might represent an appropriate screening method for evaluating vascular calcification in daily clinical practice., (© 2019 Asian Pacific Society of Nephrology.)

Background/aims: Twice-weekly hemodialysis(HD) is prevalent in the developing countries, scarce data are available for this treatment in patients with long-term dialysis vintage., Methods: 106 patients with more than 5 years HD vintage undergoing twice-weekly HD or thrice-weekly HD in a hemodialysis center in Shanghai between December 1, 2013 and December 31, 2013 were enrolled into the cohort study with 3 years follow-up. Kaplan-Meier analysis and Cox proportional hazards models were used to compare patient survival between the two groups. Subgroup analysis of 62 patients more than 10 years HD vintage was also performed according to their different dialysis frequency., Results: Compared with patients on thrice-weekly HD, twice-weekly HD patients had significantly longer HD session time and higher single-pool Kt/V (spKt/V) (session time, 4.59±0.45 vs 4.14±0.31 hours/per session, P< 0.001; spKt/V, 2.12±0.31 vs 1.83±0.30, P< 0.001). Kaplan-Meier survival analysis indicated that the two groups had similar survival (P=0.983). Multivariate Cox regression analysis showed that age and time-dependent serum albumin were predictors of patient mortality. Subgroup analysis of 62 patients more than 10 years HD vintage also indicated that the two groups had similar survival. During the follow-up, 4 patients dropped out from the twice-weekly HD group and transferred to thrice-weekly HD., Conclusion: The similar survival between twice-weekly HD and thrice-weekly HD in patients with long-term dialysis vintage is likely relating to patient selection, individualized treatment for dialysis patients based on clinical features and socioeconomic factors remains a tough task for the clinicians., (© 2018 The Author(s). Published by S. Karger AG, Basel.)