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Background Blood pressure (BP) control is an important factor in the management of chronic kidney disease (CKD). Several studies have shown that BP in many patients with CKD remained uncontrolled even with multiple medications. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor (ARNI), has been newly approved for treating hypertension in Japan. However, the renoprotective effects remain unclear, particularly in patients with advanced CKD. Here, we investigated the effects on proteinuria of this ARNI in patients with stage 4–5 CKD. Methods We retrospectively collected data from outpatients with stage 4–5 CKD who started ARNI from January until December 2023. The primary outcome was the change in urine protein creatinine ratio (UPCR) at 6 months after ARNI initiation. Secondary outcomes were systolic and diastolic BP, estimated glomerular filtration rate (eGFR), serum potassium, and serum uric acid (UA). We analyzed factors associated with 50% UPCR reduction by multivariate analysis. Results In total, 47 patients were analyzed. ARNI reduced UPCR from 2.14 g/gCr (interquartile range; 1.09–2.91) to 1.05 g/gCr (0.42–1.95; p  < 0.001). Systolic BP fell from 150.0 mmHg (139.5–160.0) to 134.0 mmHg (124.5–140.0; p  < 0.001). No significant changes in eGFR, serum potassium, and serum uric acid were observed, except for a slight decrease in eGFR among patients with conversion from a renin–angiotensin system inhibitor to ARNI. In multivariate regression analysis, higher systolic BP (per 10-mmHg increase) was significantly associated with reduced proteinuria (odds ratio 2.51, 95% confidence interval 1.35–4.66; p  = 0.004). Conclusions ARNI reduced proteinuria in patients with stage 4–5 CKD, particularly for those with uncontrolled hypertension.

BackgroundSodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.MethodsThis phase 2/3, randomized, double-blind, placebo-controlled, dose–response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK+) concentrations ≥ 5.1– ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK+ over 48 h. The proportion of patients with normokalemia (sK+ 3.5–5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated.ResultsOverall, 103 patients (mean age, 73.2 years; range 50–89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK+ change from 0 to 48 h versus placebo was − 0.00261 (SZC 5 g) and – 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK+  < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported.ConclusionSZC is effective and well tolerated in Japanese patients with hyperkalemia.

ObjectivesWe aimed to examine the validity of the quick Sequential Organ Failure Assessment (qSOFA) score for mortality and bacteraemia risk assessment in Japanese haemodialysis patients.DesignThis is a retrospective multicentre cohort study.SettingThe six participating hospitals are tertiary-care institutions that receive patients on an emergency basis and provide primary, secondary and tertiary care. The other participating hospital is a secondary-care institution that receives patients on an emergency basis and provides both primary and secondary care.ParticipantsThis study included haemodialysis outpatients admitted for bacteraemia suspicion, who had blood drawn for cultures within 48 hours of their initial admission.Primary and secondary outcome measuresThe primary outcome measure was overall in-hospital mortality. Secondary outcomes included 28-day in-hospital mortality and the incidence of bacteraemia diagnosed based on blood culture findings. The discrimination, calibration and test performance of the qSOFA score were assessed. Missing data were handled using multiple imputation.ResultsAmong the 507 haemodialysis patients admitted with bacteraemia suspicion between August 2011 and July 2013, the overall in-hospital mortality was 14.6% (74/507), the 28-day in-hospital mortality was 11.1% (56/507) and the incidence of bacteraemia, defined as a positive blood culture, was 13.4% (68/507). For predicting in-hospital mortality among haemodialysis patients, the area under the receiver operating characteristic curve was 0.61 (95% CI 0.56–0.67) for a qSOFA score ≥2. The Hosmer-Lemeshow χ2 statistics for the qSOFA score as a predictor of overall and 28-day in-hospital mortality were 5.72 (p=0.02) and 7.40 (p<0.01), respectively.ConclusionOn external validation, the qSOFA score exhibited low diagnostic accuracy and miscalibration for in-hospital mortality and bacteraemia among haemodialysis patients.

BackgroundReportedly, thiamine deficiency, resulting from malnutrition and long-term diuretic therapy, is observed in patients with chronic kidney disease (CKD). The risk of thiamine deficiency might be enhanced, especially in end-stage CKD patients. Here, we assessed thiamine status in incident dialysis patients.MethodsThis study was a single-center cross-sectional study which included 288 consecutive patients initiated into dialysis between April 2013 and March 2017 at our hospital. Thiamine status was evaluated by high-performance liquid chromatography of whole blood samples. We evaluated the association between blood thiamine concentration and other clinical parameters.ResultsOf the 288 patients, 21 patients receiving thiamine supplementation at the time of dialysis initiation and 26 patients without blood thiamine measurements were excluded. In 30 patients (12.4%), blood thiamine concentration was lower than the lower limit of normal (21.3 ng/mL; dotted line). Blood thiamine concentration correlated with age, body mass index, and Barthel index (BI) score (p = 0.008, 0.012 and 0.009, respectively). Stepwise multivariate regression analysis indicated that BI scores were independent risk factors for thiamine deficiency (β coefficients = 0.169, p = 0.013).ConclusionsThe proportion of end-stage CKD patients with low blood thiamine concentration is high. Low physical function (low BI score) is an independent risk factor of thiamine deficiency. Clinicians should be aware of thiamine deficiency in end-stage CKD patients, especially those with low physical function.

Background The number of elderly dialysis patients in Japan is dramatically increasing. Receiving therapy with better satisfaction through home care is one of the important factors in their daily lives. Thus, the quality of life of elderly patients on hemodialysis (HD) or peritoneal dialysis (PD) was evaluated. Methods Clinical information of patients aged ≥80 years who started dialysis at our hospital between January 2013 and December 2015 was retrospectively collected. The mortality rate, length of hospitalization, and place of death were identified to evaluate patient quality of life. Results In total, 56 patients (14 PD and 42 HD) were enrolled. The mean age of study subjects was 85.2 ± 4.0 years. The proportion of PD patients who lived with their family or have professional caregivers who could assist them in their daily life was higher than that of HD patients (100 vs. 76.2%, respectively; p  = 0.044). Mortality rate was higher in PD patients than in HD patients ( p  = 0.003), but long-term hospitalization of >180 days was observed only in HD patients (PD vs. HD: 0.0 vs. 16.7%; p  = 0.102). In patients with Barthel index scores <100, the long-term hospitalization difference was significant (PD vs. HD: 0.0 vs. 30.4%; p  = 0.040). Of note, 6 of 7 deceased PD patients and 1 of 10 deceased HD patients died at home ( p  = 0.002). Conclusion PD is a desirable home care therapy for elderly patients, but the burden on caregivers should be considered.

Immunoglobulin A (IgA) nephropathy is a disease that presents with urinary symptoms such as glomerular hematuria and urinary protein positivity, with predominant deposition of IgA in the mesangial region of the glomerulus. Corticosteroids are mainly used for treatment; however, infection is a serious adverse event, and evidence regarding therapeutic efficacy is insufficient, thus new treatments are strongly desired. Mesenchymal stem cells (MSCs) contribute to the amelioration of inflammation and recovery of organ function in inflammatory environments by converting the character of leukocytes from inflammatory to anti-inflammatory and inducing the proliferation and differentiation of organ component cells, respectively. These properties of MSCs have led to their clinical application in various inflammatory diseases, but this study is the first clinical trial of MSCs for refractory glomerulonephritis in the world. This study is registered and assigned the number, jRCT2043200002 and NCT04342325. This will be a phase 1, open-label, multiple-center, dose-escalation study of adult patients with refractory IgA nephropathy resistant to or difficult to treat with existing therapies. ADR-001 will be administered intravenously to from three to six patients at a dose of 1 × 10 cells once in the first cohort and to six patients twice at 2-week intervals in the second cohort, and observation will continue until 52 weeks. The primary endpoint will be the evaluation of adverse events up to 6 weeks after the start of ADR-001 administration. Secondary endpoints will be the respective percentages of patients with adverse events, clinical remission, partial remission, remission of urine protein, remission of hematuria, time to remission, changes in urine protein, hematuria, and estimated glomerular filtration rate. Following the administration of ADR-001 to patients with IgA nephropathy, the respective percentages of patients with adverse events, asymptomatic pulmonary emboli, clinical remission, partial remission, urine protein remission, hematuria remission, their time to remission, changes in urine protein, hematuria, and glomerular filtration rate will be determined. This study will evaluate the safety and tolerability of ADR-001 and confirm its therapeutic efficacy in adult patients with refractory IgA nephropathy.

Background Renin-angiotensin system inhibitors (RASIs), either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, are widely used in patients with non-dialysis chronic kidney disease, as a renin-angiotensin system (RAS) blockade has renoprotective effects. Several studies show that preserving residual renal function is important for a better prognosis in peritoneal dialysis (PD) patients. Here, we systematically reviewed the beneficial or harmful effects of RAS blockade in PD patients. Methods PubMed, the Cochrane Library, Embase, the Ichushi web databases, and other resources were selected to search clinical guidelines, systematic reviews, and randomized controlled trials (RCT) published before April 14, 2017, using “peritoneal dialysis,” “angiotensin-converting enzyme inhibitors,” “angiotensin II type 1 receptor blockers,” and “randomized controlled trial” as keywords. Desired results were total mortality, technical survival, urine volume, residual renal function calculated by glomerular filtration rate (GFR), cardiovascular events, and anuria progression rate. The study protocol is registered in PROSPERO (International Prospective Register of Systematic Reviews) under the registration number CRD42018104106. Results Of a total of 339 studies, eight were identified as suitable for the analysis. Only one study was blinded, whereas the other seven studies were open-label. RASI appeared to preserve residual renal function, GFR (4 studies, 163 participants, mean difference [MD] 0.97 mL/min/1.73 m 2 , 95% confidence interval [CI] 0.49–1.44), and urine volume (6 studies, 194 participants, MD 142.56 mL 95% CI 25.42–259.69), although there were no beneficial effects of RASI on total mortality, technical survival, cardiovascular events, and anuria rate. Conclusions Our analysis found that RASIs contribute to preserving GFR and urine volume in PD patients. As the number of study participants is small, further studies with a larger sample size are required.

Background Catheter malposition is one of the reasons for outflow failure in peritoneal dialysis (PD) patients. Fluoroscopic manipulation is a non-surgical treatment option for catheter malposition. We retrospectively analyzed the efficacy and safety of fluoroscopic manipulation using an alpha-replacer guidewire. Methods The alpha-replacer (JMS Co. Ltd., Tokyo, Japan) is a guidewire for the treatment of catheter malposition. We used the alpha-replacer in 23 PD cases at our hospital from January 2008 to December 2012. We evaluated body mass index, time interval between catheter placement and malposition, and interval between catheter exteriorization and malposition. Primary failure was defined as malposition at the time of catheter exteriorization, and secondary failure as malposition after functional PD therapy (correct position at time of exteriorization). Results Successful catheter replacement rate using the alpha-replacer was 60.8 % (14 of 23 cases). This was similar to the rates in previous reports. Successful replacement was mostly observed in those with a long interval between catheter placement and malposition ( p  = 0.048), between catheter placement and exteriorization ( p  = 0.047) and with secondary failure ( p  = 0.030). In multivariate analysis, secondary failure cases had a higher rate of successful replacement than primary failure cases (odds ratio [OR] 7.33, p  = 0.038). Serious complications, such as abdominal trauma or peritonitis, were not observed. Conclusion Fluoroscopic manipulation using an alpha-replacer may be safe and effective for the management of peritoneal catheter malposition, particularly in patients who were under functional PD therapy until catheter malposition.