BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People

OBJECTIVES: This study aimed to explore the impact of chronic kidney disease (CKD) on prognosis of patients older than 80 years after hip fracture. METHODS: This retrospective, observational, single-center study included patients older than 80 years who underwent hip fracture operations between Feburary 2013 to June 2021 at our hospital. Patients were divided into CKD and non-GKD groups based on the estimated glomerular filtration rate (eGFR) < 60 mL/(min·1.73m²)] or not. Outcomes were the incidence of in-hospital postoperative infectious and non-infectious complications, 30-day readmission, and in-hospital death. Logistic regression analysis was used to calculate the odds ratio (OR) of CKD on these outcomes. RESULTS: A total of 498 patients were included, 165 in the CKD group and 333 in the non-CKD group. Eighty-seven (52.7%) CKD patients experienced 140 episodes of postoperative complications. In comparison, 114 (34.2%) non-CKD patients had 158 episodes of postoperative complications. CKD patients were more likely to have postoperative complications than non-CKD patients (OR = 2.143, 95% CI: 1.465-3.134, P < 0.001). CKD increased the risk of cardiovascular complications (OR = 2.044, 95% CI: 1.245-3.356, P = 0.004), acute kidney injury (OR = 3.401, 95% CI: 1.905-6.072, P < 0.001), delirium (OR = 2.276, 95% CI: 1.140-4.543, P = 0.024), and gastrointestinal bleeding (OR = 4.151, 95% CI: 1.025-16.812, P = 0.031). The transfusion rate (OR = 2.457, 95% CI: 1.668-3.618, P < 0.001) and incidence of 30-day readmission (OR = 2.426, 95% CI:1.203-4.892, P = 0.011) in CKD patients were significantly higher than those in patients without CKD. CONCLUSIONS CKD is associated with poor postoperative outcomes in geriatric hip fracture patients. Special attention should be paid to patients with CKD.
Humans ; Renal Insufficiency, Chronic/physiopathology* ; Aged, 80 and over ; Postoperative Complications/epidemiology* ; Hip Fractures/complications* ; Male ; Female ; Patient Readmission/statistics & numerical data* ; Retrospective Studies ; Glomerular Filtration Rate

Growth disorders are one of the common complications of chronic kidney disease (CKD) in children, adversely affecting both the quality of life and survival time of CKD patients. Recombinant human growth hormone (rhGH) is an effective treatment for growth disorders in children with CKD. This article reviews the mechanisms underlying growth disorders in children with CKD, the therapeutic effects, safety, and precautions of rhGH, and long-term management of diagnosis and treatment of this disorder.
Humans ; Human Growth Hormone/adverse effects* ; Child ; Recombinant Proteins/adverse effects* ; Renal Insufficiency, Chronic/complications* ; Growth Disorders/etiology*

In patients with chronic kidney disease(CKD),the incidence of cardiovascular events and the mortality rate are significantly higher than those in the general population.Approximately 85% of end-stage CKD patients develop hyperhomocysteinemia(HHcy)due to impaired renal function.It is not yet fully determined whether HHcy merely acts as a biomarker of CKD or plays a role in the pathogenesis.Although supplementation with folic acid and other B vitamins(B6 and B12)has been proven to lower the plasma level of total homocysteine,their effectiveness in slowing CKD progression or reducing cardiovascular complications remains uncertain.This article reviews the latest research progress in the relationship between HHcy and CKD,aiming to give new insights into the prevention and treatment of CKD and its complications.
Humans ; Hyperhomocysteinemia/complications* ; Renal Insufficiency, Chronic/complications*

INTRODUCTION: Management of aortic stenosis (AS) in patients with chronic kidney disease (CKD) may often be overlooked, and this could confer poorer outcomes. METHODS: Consecutive patients ( n = 727) with index echocardiographic diagnosis of moderate to severe AS (aortic valve area <1.5 cm 2 ) were examined. They were divided into those with CKD (estimated glomerular filtration rate < 60 mL/min) and those without. Baseline clinical and echocardiographic parameters were compared, and a multivariate Cox regression model was constructed. Clinical outcomes were compared using Kaplan-Meier curves. RESULTS: There were 270 (37.1%) patients with concomitant CKD. The CKD group was older (78.0 ± 10.3 vs. 72.1 ± 12.9 years, P < 0.001), with a higher prevalence of hypertension, diabetes mellitus, hyperlipidaemia and ischaemic heart disease. AS severity did not differ significantly, but left ventricular (LV) mass index (119.4 ± 43.7 vs. 112.3 ± 40.6 g/m 2 , P = 0.027) and Doppler mitral inflow E to annular tissue Doppler e' ratio (E: e' 21.5 ± 14.6 vs. 17.8 ± 12.2, P = 0.001) were higher in the CKD group. There was higher mortality (log-rank 51.5, P < 0.001) and more frequent admissions for cardiac failure (log-rank 25.9, P < 0.001) in the CKD group, with a lower incidence of aortic valve replacement (log-rank 7.12, P = 0.008). On multivariate analyses, after adjusting for aortic valve area, age, left ventricular ejection fraction and clinical comorbidities, CKD remained independently associated with mortality (hazard ratio 1.96, 95% confidence interval 1.50-2.57, P < 0.001). CONCLUSION Concomitant CKD in patients with moderate to severe AS was associated with increased mortality, more frequent admissions for cardiac failure and a lower incidence of aortic valve replacement.
Humans ; Aortic Valve Stenosis/surgery* ; Male ; Female ; Renal Insufficiency, Chronic/complications* ; Aged ; Aged, 80 and over ; Middle Aged ; Severity of Illness Index ; Glomerular Filtration Rate ; Proportional Hazards Models ; Echocardiography ; Kaplan-Meier Estimate ; Retrospective Studies ; Aortic Valve/surgery* ; Echocardiography, Doppler

Humans ; Diabetes Mellitus, Type 2/therapy* ; Self Care ; Renal Insufficiency, Chronic/complications*

As the incidence of diabetes mellitus is rapidly increasing worldwide,that of related complications,such as diabetic kidney disease(DKD),also increases,conferring a heavy economic burden on the patients,families,society,and government.Diabetes mellitus complicated with chronic kidney disease(CKD)includes DKD and the CKD caused by other reasons.Because of the insufficient knowledge about CKD,the assessment of diabetes mellitus complicated with CKD remains to be improved.The therapies for diabetes mellitus complicated with CKD focus on reducing the risk factors.In clinical practice,DKD may not be the CKD caused by diabetes.According to clinical criteria,some non-diabetic kidney disease may be misdiagnosed as DKD and not be treated accurately.This review summarizes the status quo and research progress in the assessment,diagnosis,and treatment of diabetes mellitus complicated with CKD and predicts the directions of future research in this field.
Humans ; Diabetes Mellitus, Type 2/complications* ; Diabetic Nephropathies/etiology* ; Renal Insufficiency, Chronic/therapy* ; Risk Factors ; Diabetes Mellitus/therapy*

OBJECTIVE: To investigate the factors related to renal impairment in patients with diabetic kidney disease (DKD) from the perspective of integrated Chinese and Western medicine. METHODS: Totally 492 patients with DKD in 8 Chinese hospitals from October 2017 to July 2019 were included. According to Kidney Disease Improving Global Outcomes (KDIGO) staging guidelines, patients were divided into a chronic kidney disease (CKD) 1-3 group and a CKD 4-5 group. Clinical data were collected, and logistic regression was used to analyze the factors related to different CKD stages in DKD patients. RESULTS: Demographically, male was a factor related to increased CKD staging in patients with DKD (OR=3.100, P=0.002). In clinical characteristics, course of diabetes >60 months (OR=3.562, P=0.010), anemia (OR=4.176, P<0.001), hyperuricemia (OR=3.352, P<0.001), massive albuminuria (OR=4.058, P=0.002), atherosclerosis (OR=2.153, P=0.007) and blood deficiency syndrome (OR=1.945, P=0.020) were factors related to increased CKD staging in patients with DKD. CONCLUSIONS Male, course of diabetes >60 months, anemia, hyperuricemia, massive proteinuria, atherosclerosis, and blood deficiency syndrome might indicate more severe degree of renal function damage in patients with DKD. (Registration No. NCT03865914).
Humans ; Male ; Diabetes Mellitus, Type 2 ; Diabetic Nephropathies ; Hyperuricemia ; Kidney ; Proteinuria ; Renal Insufficiency, Chronic/complications*

OBJECTIVES: Diabetic kidney disease is one of the most serious complications of diabetes mellitus (DM), and it is a main cause for chronic kidney disease and end-stage kidney disease (ESRD). It is important to find out the factors that cause the progression of renal function. The study aims to explore the relationship between serum uric acid (SUA) trajectory and the progression of renal function in patients with Type 2 diabetes mellitus (T2DM). METHODS: A total of 846 patients with T2DM, who were admitted to the Department of Nephrology and Endocrinology, the Third Xiangya Hospital of Central South University, from January 2009 to December 2021 and met the criteria of baseline estimated glomerular filtration rate (eGFR)≥60 mL/(min·1.73 m²), were selected as the research subjects. The SUA data of multiple measurements were collected and identified as different SUA trajectories by group-based trajectory modeling (GBTM). According to the SUA trajectories, the patients were divided into a low trajectory group (105 cases), a middle trajectory group (396 cases), a middle high trajectory group (278 cases), and a high trajectory group (67 cases). Cox regression analysis was used to examine the effect of SUA trajectory on the progression of renal function in patients with T2DM. Subgroup analysis was performed by sex, age, course of disease, body mass index (BMI) and hemoglobin A1c (HbA1c). RESULTS: The median follow-up was 4.8 years. At the end of follow-up, 158 patients had different degrees of decline in renal function. After adjusting for multiple confounding factors by Cox regression analysis, the risks of eGFR<60 mL/(min·1.73 m²), eGFR reduction rate≥50%, serum creatinine (Scr) doubling and composite endpoint (eGFR reduction rate≥50%, Scr doubling or ESRD) in the high trajectory group were significantly higher than those in the low trajectory group, with HR of 3.84 (95% CI 1.83 to 8.05), 6.90 (95% CI 2.27 to 20.96), 6.29 (95% CI 2.03 to 19.52), and 8.04 (95% CI 2.68 to 24.18), respectively. There was no significant difference in the risk of ESRD among the above 4 groups (all P>0.05). Subgroup analysis showed that: compared with the low trajectory group, the risks of eGFR<60 mL/(min·1.73 m²) in patients with high trajectory in the subgroup of male, female, age<65 years, course of disease<10 years, BMI≥24 kg/m² and HbA1c≥7% were increased (all P<0.05). The SUA trajectory had no interaction with sex, age, course of disease, BMI and HbA1c (all interactive P>0.05). CONCLUSIONS The high SUA trajectory increases the risk for progression of renal function in patients with T2DM. Long-term longitudinal changes of SUA should be paid attention to.
Humans ; Male ; Female ; Aged ; Diabetes Mellitus, Type 2/complications* ; Cohort Studies ; Uric Acid ; Glycated Hemoglobin ; Renal Insufficiency, Chronic ; Kidney Failure, Chronic/complications* ; Glomerular Filtration Rate ; Kidney/physiology* ; Risk Factors

Vascular calcification is the crucial factor of high cardiovascular disease morbidity and mortality in patients with chronic kidney disease (CKD), which causes a huge medical and economic burden. It is urgent to explore its pathogenesis and intervention methods. CKD-associated vascular calcification is an ectopic osteogenesis process actively regulated by multiple cells. Vascular smooth muscle cells (VSMCs) undergo osteogenic differentiation in a pro-calcification environment, and secrete matrix vesicles to form calcium and phosphorus crystal deposition sites, which are key events in the development of CKD-associated vascular calcification. This article reviews the new mechanism and technology of CKD-associated vascular calcification and discusses the role of the myokine Irisin in CKD-associated vascular calcification.
Humans ; Osteogenesis ; Renal Insufficiency, Chronic ; Vascular Calcification/pathology* ; Proteins ; Cardiovascular Diseases/complications* ; Disease Progression ; Myocytes, Smooth Muscle