bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0880EFFICACY AND SAFETY OF SEVELAMER CARBONATE IN NON-DIALYSIS HYPERPHOSPHATEMIA PATIENTS: A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP STUDY FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN PATIENTS WITH CHRONIC KIDNEY DISEASE NOT ON DIALYSIS IN CHINA
Authors: Yu Xueqing 
Published: June 2020

Abstract

Background and Aims
Hyperphosphatemia in chronic kidney disease (CKD) patients is associated with adverse outcomes, including vascular calcification, increasing risks of disease progression and even death. Sevelamer carbonate have been approved in Europe for phosphate lowering treatment in pre-dialysis CKD patient, its efficacy and safety in Chinese CKD hyperphosphatemia patients are not previously reported.

Method
This was a phase III, multi-center, randomized, double blind, placebo-controlled, balanced (1:1, sevelamer: placebo) parallel-group study to evaluate the efficacy and safety of sevelamer carbonate versus placebo over 8 weeks’ duration in hyperphosphatemic CKD patients not on dialysis in China (Registration number NCT03001011). The primary objective of this study is to demonstrate efficacy of sevelamer carbonate tablets in the reduction of serum phosphorus in hyperphosphatemia in patients with chronic kidney disease (CKD) not on dialysis.

Results
In all, 202 patients were randomized (sevelamer, n=101; placebo, n=101); mean age was 50.7 years, 53.5% were male and the mean time of CKD diagnosis was 3.4 years with mean eGFR 7.5 ml/min/1.73 m2. The baseline phosphorous were 2.13±0.35 mmol/L and 2.12±0.37 mmol/L in sevelamer and placebo group, respectively. The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate (-0.22±0.47 mmol/L) compared with placebo (0.05±0.44 mmol/L) (mean difference between sevelamer carbonate and placebo was -0.26 mmol/L, P&lt;0.0001). When compared with placebo, sevelamer carbonate significantly reduced serum total cholesterol (-0.90±0.85 vs. -0.06±0.68 mmol/L, P&lt;0.0001), low-density lipoprotein cholesterol (-0.94±0.72 vs. -0.04±0.58 mmol/L, P&lt;0.0001) and calcium-phosphorous product (-0.48±0.97 vs. 0.05±0.81 mmol2/L2) from baseline to week 8. Serum iPTH was not significantly changed in sevelamer carbonate group compared with placebo group (-9.60±136.00 vs. 7.61±141.92 ng/L, P=0.83). Sevelamer carbonate was well tolerated with 83.27% compliance compared with 82.19% compliance in placebo arm. Average dose of sevelamer carbonate was 7.51 g/d at the end of study and 4.52 g/d across the study. Adverse events experienced by patients in sevelamer carbonate and placebo group were similar.

Conclusion
This study demonstrated that sevelamer carbonate has produced a significant reduction of serum phosphorous, and is safe and tolerated in Chinese pre-dialysis CKD patients with hyperphosphatemia.
P0901REAL-WORLD ASSESSMENT: CLINICAL EFFECTIVENESS AND SAFETY OF VITAMIN D THERAPIES IN ND-CKD PATIENTS
Authors: Germain Michael J , Paul Subir K , Broumand Varshasb , Fadda George , Nguyen Andy , McGarvey November , Gitlin Matthew , Ashfaq Akhtar 
Published: June 2020

Abstract

Background and Aims
Extended-release calcifediol (ERC), active vitamin D analogs (VDA), and nutritional vitamin D (NVD) are the predominant vitamin D therapies (VDTs) commonly used for treatment (Tx) of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 non-dialysis chronic kidney disease (ND-CKD) and vitamin D insufficiency (VDI). Clinical trials have demonstrated varying efficacy on serum total 25-hydroxyvitamin D (25D) and intact parathyroid hormone (iPTH) across VDTs. This study aimed to descriptively assess the real-world experience of various VDTs in increasing 25D, reducing iPTH, and modifying serum calcium (Ca).

Method
Medical records of the first 376 adult patients with stage 3 or 4 CKD and a history of SHPT and VDI who met study criteria from 18 geographically representative United States nephrology clinics were reviewed from 1 year before through 1 year after initiation of VDT. Key study variables included patient demographics, medication usage, and laboratory results. The study population had a mean age of 69.5 years with gender and racial distributions representative of the US ND-CKD population. Patients were stratified into cohorts based on their index therapy at index date: ERC (n=174), VDA (n=55) and NVD (n=147).

Results
Patients treated with NVD were predominantly CKD Stage 3 (69.4%), while CKD Stage 4 were the majority of those treated with ERC (53.4%) and VDA (61.8%). The ERC Tx’ed subjects demonstrated an increase in 25D by 23.7 ± 1.6 ng/mL (p&lt;0.001) and a decrease iPTH by 35 ± 6.2 pg/mL (p&lt;0.001) without statistically significant impact on serum calcium (Ca) and phosphorus (P) levels. The VDA Tx’ed group demonstrated an increase in 25D by 5.5 ± 1.3 ng/mL (p&lt;0.001) without statistically significant impact on iPTH and serum phosphorus levels. Additionally, serum Ca increased by 0.2 ± 0.1 pg/mL (p&lt;0.001) among VDA recipients. The NVD Tx’ed group demonstrated an increase in 25D by 9.7 ± 1.6 ng/mL (p&lt;0.001) without statistically significant impact on iPTH and serum Ca and P levels (Table 1).

Conclusion
Clinical effectiveness and safety varied across VDTs. ERC was the only VDT which significantly reduced mean iPTH in the real world setting despite highest mean levels at baseline among the three cohorts. Additionally, subjects treated with ERC demonstrated the largest mean increase in 25D and ERC was the only VDT which raised mean 25D to the normal range (&gt;30 ng/mL). Patients treated with ERC and NVD saw no statistically significant impact on serum Ca and P levels; however, those treated with VDAs saw a small, but statistically significant increase in serum Ca levels.
P0904EFFECT OF EMPAGLIFLOZIN ON SERUM MARKERS OF OSTEOCYTE AND OSTEOBLAST FUNCTION AND ALBUMINURIA IN DIABETIC AND NON-DIABETIC PATIENTS WITH CHRONIC KIDNEY DISEASE
Authors: Masajtis-Zagajewska Anna , Pä™czek Katarzyna , Holub Tomasz , Nowicki Michal 
Published: June 2020

Abstract

Background and Aims
Sodium-glucose co-transporter 2 (SGLT2) inhibitors are new class of oral antidiabetic drugs that show potent cardio- and nephroprotective actions. Despite having a favorable safety profile the treatment with SGLT2 inhibitors has been associated with several side-effects including increased risk of fractures. Although the pathomechanism of this complication has not been elucidated these drugs may inhibit tubular reabsorption of phosphate which may stimulate a secretion of fibroblast growth factor 23 (FGF23).
The study was designed to assess the effect of SGLT2 inhibitor on markers of calcium-phosphate metabolism, bone turnover and early glomerular injury in diabetic and non-diabetic patients with stage 3 chronic kidney disease (CKD).

Method
41 patients with chronic kidney disease including 23 without diabetes (13 M, 11F, age 52.9±0.7 years, estimated glomerular filtration rate (eGFR) 38.6±10.8 ml/min/1.73 m2) and 18 with type 2 diabetes (12 M, 6F, age 58.8±1.4 years, eGFR 38.8±7.7 ml/min/1.73 m2) were recruited. Main inclusion criteria were CKD stage 3 and urine albumin secretion &gt;100 mg/g creatinine. All subjects received oral empagliflozin 10 mg once daily for 7 days.
Serum calcium, phosphorus, parathormone (PTH), calcitriol, bone alkaline phosphatase (BAP), FGF23 and urine calcium, phosphate and albumin were measured at baseline and after 7 days of empagliflozin treatment.

Results
Plasma calcitriol, serum and urine calcium, phosphorus and BAP did not change significantly during the administration of empagliflozin. Urine phosphate/creatinine ratio was similar in both subgroups at baseline and did not change during empagliflozin administration. Plasma PTH was higher in non-diabetics than in diabetics both at baseline and after empagliflozin. The increase of PTH after empagliflozin tended to be higher in diabetic patients (p=0.07). There was only a trend towards an increase of serum FGF23 in both non-diabetic and diabetic subgroup (by 4.2±0.2 vs. 9.3±1.1 pg/mL, ns). BAP was significantly higher at baseline in diabetic patients but did not significantly change after empagliflozin in the subgroups.
Albumin/creatinine ratio decrease after empagliflozin administration was significant only in non-diabetic patients (-62±17 vs. -2±8 mg/g in diabetic patients, p=0.03 for difference).

Conclusion
Our study showed no effect of short-time administration of empagliflozin on calcium-phosphate and bone metabolism markers in patients with both diabetic and non-diabetic CKD. Empagliflozin decreased albuminuria significantly only in non-diabetic CKD that may suggest a potentially greater nephroprotective effect of this SGLT2 inhibitor in non-diabetic than in diabetic nephropathy.
P0905INFLUENCE OF TUMOR NECROSIS FACTOR ON MINERAL BONE DISEASE IN ESRD PATIENTS
Authors: Tosic Dragovic Jelena , Dimkovic Nada , Popovic Jovan , Djuric Petar , Naumovic Radomir 
Published: June 2020

Abstract

Background and Aims
Serum levels of parathyreoid hormone is the main cause of mineral disorders in patients on chronic hemodialysis, and it well known that this hormone acts as an uremic toxine and contributes to oxidative stress and overall mortality rate. However, there are many observations which imply that the protean manifestations of renal bone disease cannot be explained simply by abnormalities of PTH or vitamin D metabolites. For example, levels of PTH correlate relatively poorly with various parameters of bone histology. It has been shown that uremia leads to cytokijne imbalance with overbalance of proinflammatory citokines such as TNF. Also, studies showed that calcimimetic therapy decreases not only PTH levels, but also levels of TNF. The aim was to analyse tumor necrosis factor (TNF) gene polymorphisms in group of hemodialysis patients and to correlate the findings with presence of secondary hyperparathyroidism.

Method
This cross sectional study included 202 patients on regular hemodialysis for more than six months in University Medical Centar Zvezdara. Venous blood for genotyping and for PTH analysis was collected on midweek dialysis session from each patient. Genetic analysis was performed by using polymerase chain reaction. Patients are diveded in two groups regarding the level of PTH, so that first group had normal PTH levels or mild SHPT, while patients in second group had sever SHPT. We analysed influence of genetic polymorphism for TNF on apperance of SHPT.

Results
The results have shown 3 fold lower risk for developing SHPT in GG homozygots for TNF gene with statistical significance (p=0,01)- Table 1.

Conclusion
Parathyreoid gland hyperfunction is multifactorial disorder and there are emerging evidence that cytokines as endogenous modulators have an important impact on its pathogenesis.
P0918LONGITUDINAL TRAJECTORIES OF NUTRITIONAL PARAMETERS WITH ORAL NUTRITIONAL SUPPLEMENT USE AMONG NON-DIALYSIS CHRONIC KIDNEY DISEASE PATIENTS
Authors: Wong Michelle , Renouf Dani , Zheng Sophia , Sheriff Zainab , Levin Adeera 
Published: June 2020

Abstract

Background and Aims
Malnutrition and protein-energy wasting are complications of advanced CKD associated with increased risk of mortality and morbidity. In the province of British Columbia, Canada, a Nutritional Supplement Policy stewarded by renal dietitians guides prescription of oral nutritional supplements (ONS). To date, there have been a lack of studies assessing the effects of ONS among non-dialysis CKD patients (CKD-ND). The aim of the study was to assess longitudinal trajectories of nutrition, inflammation and associated biochemical parameters following initiation of ONS among CKD-ND patients.

Method
In this retrospective cohort study of adult CKD-ND patients who initiated follow-up at multidisciplinary Kidney Care Clinics during 2013-2015, we used radar charts to examine longitudinal trajectories of nutritional, inflammation and related parameters over 2 years, among patients who had at least one ONS prescription and who had available lab data for the following 8 parameters within any given time interval: body mass index (BMI), serum albumin, bicarbonate, phosphate, parathyroid hormone, ferritin, neutrophil-to-lymphocyte ratio (NLR) and haemoglobin. Mean values of each parameter were plotted at 6-month intervals from the first prescription of ONS, up to 29 months.

Results
There were 963, 692, 569, 481, 425 patients with available data during the intervals at month 0-5, 6-11, 12-17, 18-23 and 24-29 following the first ONS prescription, respectively. Mean serum albumin increased from a mean of 37 to 40 g/L over the 29-month period after ONS initiation, while mean NLR declined from 4.5 to 3.6 (Figure). Mean serum ferritin also declined slightly from 293 to 261 µg/L at 3 months and remained stable thereafter. There were small fluctuations in mean BMI (range 24.5 to 25.1 kg/m2), bicarbonate (range 24 to 25 mmol/L), PTH (range 15.5 to 18.0 pmol/L). Mean haemoglobin rose from 108 g/L in the first interval to 116 g/L in the last interval. Mean serum phosphate changed minimally from 1.4 to 1.3 mmol/L.

Conclusion
Among CKD-ND patients who had at least one ONS prescription, serum albumin increased, while there was a decrease in inflammation parameters (NLR and ferritin), and other variables had small fluctuations over the 2+ year follow-up. Future analyses will include multivariable-adjusted models to assess the associations of ONS treatment with nutritional variables and with clinical outcomes, including progression to end-stage kidney disease.
P09235-AMINOLEVULINIC ACID PREVENTS LIPID-INDUCED ER STRESS AND APOPTOSIS BY INDUCING HEME OXYGENASE-1
Authors: Mae Yukari , Kobayashi Yui , Takata Tomoaki , Hosokawa Kohshiro , Sugihara Takaaki , Kanda Tsutomu , Isomoto Hajime 
Published: June 2020

Abstract

Background and Aims
A growing number of evidence indicates the association with dyslipidemia and the progression of chronic kidney disease. Endoplasmic reticulum (ER) stress and apoptosis in renal tubule are suggested to be linked to the pathophysiology of toxic lipid-induced kidney injury. 5-aminolevulinic acid (ALA) is a precursor of heme oxygenase (HO)-1, which plays an important role in protecting cells from various stresses. In the present study, we aimed to investigate the therapeutic effect of ALA, on toxic lipid-induced ER stress and apoptosis in the renal tubule.

Method
Renal proximal tubular epithelial cells (RPTECs) were treated with palmitic acid to induce ER stress and apoptosis. ALA was also added with palmitic acid (PA). The gene and protein expressions of NF E2-related factor 2, HO-1, glucose-regulated protein (GRP)78, and C/EBP-homologous protein (CHOP) were quantified. Apoptotic cells were evaluated by caspase-3/7 assay. An HO-1 inhibitor, Zn-protoporphyrin IX, was added to investigate the involvement of HO-1 in ALA-mediated therapeutic effect on the ER stress and apoptosis.

Results
The expressions of GRP78 and CHOP increased in cells treated with PA. Apoptotic signals also increased with PA treatment. ALA induced a significant increase in the HO-1 expression and that led to the suppression of ER stress response. Apoptotic signals in PA-treated cells also decreased with ALA and the effect of ALA disappeared when combined with Zn-protoporphyrin IX.

Conclusion
PA-induced ER stress and apoptosis in RPTECs. ALA has a therapeutic effect by suppressing ER stress, possibly through HO-1 induction.
P0928PHYSICALLY ACTIVE PATIENTS IN HEMODIALYSIS: DO THEY HAVE A DIFFERENT EATING PATTERN AND BODY COMPOSITION?
Authors: Garagarza Cristina , Valente Ana , Caetano Cristina , Ramos Inês , Pinto Mariana , Oliveira Telma , Ferreira Manuel Anibal A , Sousa Guerreiro Catarina 
Published: June 2020

Abstract

Background and Aims
Body composition influences outcomes in hemodialysis (HD) patients. These patients need to follow specific nutritional recommendations and physical activity has been highly encouraged. The aim of this study was to evaluate if there are differences in body composition and in dietary patterns between physically active and no physically active HD patients.

Method
This was a multicenter observational cross-sectional study where 582 HD patients from 38 dialysis centers were enrolled. Clinical parameters were recorded and body composition analysis was performed with the Body Composition Monitor®. Dietary intake and physical activity were obtained respectively from the Food Frequency Questionnaire and from the International Physical Activity Questionnaire, both validated for the Portuguese population. For the analysis, patients were divided in 2 groups: physically active (PA), if they follow the World Health Organization recommendations, and no physically active (NPA). T-student and non-parametric tests were performed to compare means and medians respectively. A p&lt;0.05 was considered significant.

Results
Mean age was 67.8 ±17.7 years, 41.4% were female, 31.6 % had diabetes mellitus and median HD vintage was 65 (Interquartil range:43-104) months. PA patients were younger (p&lt;0.001) and had a higher energy intake (p= 0.017), protein (p=0.016), total fat (p=0.023) and omega 3 fatty acids (p=0.006). Regarding body composition; higher total body water (p=0.027), intracellular water (p=0.002), lean tissue index (p=0.002), % lean tissue mass (p=0.001), body cell mass (p=0.001) and lower % fat (p=0.003) was found in PA patients. Urea pre-dialysis (p=0.013), albumin (p=0.026), creatinine (p&lt; 0.001) and 6 months weight gain (p=0.047) were higher in PA patients whereas age-adjusted Charlson comorbidity index (p&lt;0.001) was lower in these patients. No statistically significant differences were observed among other nutrients or parameters studied nor in body mass index, HD vintage or overhydration.

Conclusion
These data shows that, after comparing PA patients with NPA, differences were observed in body composition and clinical parameters related to a better nutritional status. Moreover, the PA patients` dietary intake was more approximated to the existing recommendations for this population, namely for energy and protein daily intake.
P0935ASSOCIATION OF DIETARY INTAKE WITH SERUM LEVELS OF PHOSPHORUS AND POTASSIUM IN KOREAN HEMODIALYSIS PATIENTS USING NEWLY DEVELOPED SEMI QUANTITATIVE FOOD FREQUENCY QUESTIONNAIRE(SEMI-FFQ)
Authors: Kim Jung-Hyun , Ryu Dong-Ryeol , Kim Hyun-Jung , Kyung Min-Sook 
Published: June 2020

Abstract

Background and Aims
Dietary intake patterns in hemodialysis (HD) patients in Korea are diverse and unique comparing with those of other countries. Hyperphosphatemia and hyperkalemia are closely related to intake of dietary phosphorus and potassium. Dietary intake of Korean HD patients was analyzed using newly developed semi-FFQ for Korean food in order to get the baseline data for improving a dietary management guide for Korean HD patients.

Method
We investigate the effects of consumed food on serum phosphorus and potassium levels of 128 HD patients(74 males and 54 females) in 6 tertiary referral hospitals using semi-FFQ consisting of 23 food meal items based on the Korean usual diets.

Results
The mean age was 59.7±11.6 years for males and 58.9± 9.3 years for females and the hemodialysis duration was 5.4±5.6 years for men and 5.4±3.9 years for women, respectively. Mean serum phosphorus level was 4.50±1.52 mg/dl and mean serum potassium level was 4.74±0.73 mEq/L. Hyperphosphatemia was found in 45.8% of the subjects, and hyperkalemia in 35.4%. Energy, protein and other nutrients intake were significantly lower than the recommended intakes for HD patients (p&lt;0.05). Serum phosphorus levels showed positive correlation with intake of mixed grain meals (p&lt;0.05). There was a significant difference in the daily intake frequency of cooked rice between males (2.5±0.76/day) and females (2.15±0.86/day)(p&lt;0.001). The noodle intake frequency also showed a significant difference between males (0.09±0.14/day) and females (0.04±0.06/day) (p&lt;0.001). Serum potassium level showed positive correlation with intake of potatoes, high-potassium vegetables & fruits and Kimchi (p&lt;0.05). There was a significant gender difference in the daily intake frequency of Kimchi between males (1.28±0.11/day) and females (1.07±0.99/day)(p&lt;0.05). In case of medium and high potassium vegetables & fruits, consumption was higher in females than in males (p&lt;0.05). Intake of white rice showed negative correlation with serum potassium levels (p&lt;0.05).

Conclusion
Intake of white rice meals rather than mixed grains meals is an important factor for maintaining normal serum phosphorus and potassium levels. Intake of potatoes, medium and high potassium vegetables & fruits is recommended to be reduced to less than three serving per week. Considering abundance of potassium and phosphorus in Korean food pattern, customized dietary management as well as medical treatment is essential in all HD patients.
P0945STUDY PROTOCOL: ADIPOSE TISSUE CONTENT OF N-3 POLYUNSATURATED FATTY ACIDS AND THE RISK OF CHRONIC KIDNEY DISEASE
Authors: Hashemi Bahram , Berg Schmidt Erik , Svensson My , Lundbye-Christensen Søren , Bork Christian , Hagstrup Christensen Jeppe 
Published: June 2020

Abstract

Background
Chronic kidney disease (CKD) is associated with life style diseases such as hypertension and type 2 diabetes. However the role of diet is not yet clearly defined for development of CKD.
Recent studies have shown that n-3 polyunsaturated fatty acids (PUFAs) may exert favourable effects on several processes that may inhibit the development and progression of CKD.
A gold standard biomarker for long-term intake and metabolism of n-3 PUFAs, is their content in adipose tissue; because these fatty acids are essential and not endogenously produced.

Aims
The primary aim of this study is to investigate the association of adipose tissue content of marine and plant-based n-3 PUFAs to the risk of incident CKD.
This study will also examine associations between the content of n-3 PUFAs in adipose tissue and the risk of main subtypes of CKD: Proteinuria with unknown cause, Hypertensive nephropathy, Glomerular diseases, Diabetic nephropathy and Chronic renal failure of unknown cause.

Method
In this case-cohort study based on data from the prospective Danish Diet, Cancer and Health cohort (DCH), information concerning diet and other lifestyle factors was obtained from 57,053 Danish men and women aged 50 to 65 years, using questionnaires and interviews. Anthropometric measurements were undertaken, and adipose tissue biopsies were taken from the buttocks of all participants at baseline.
The follow-up period was from December 1993 to September 2017. The outcome CKD is defined as having a diagnosis of one of the CKDs causes in the Danish National Patient Registry (DNPR). Cases of CKD will be identified and included together with a randomly drawn subcohort, representative for all participants of the cohort. Adipose tissue samples will be analyzed by gas chromatography in all incident CKD cases and in 5,000 randomly drawn participants from the whole cohort.
The outcome will be adjusted for age, sex, body mass index, physical activity, energy intake, alcohol consumption, fermented dairy products, education, smoking status, hormone replacement therapy and comorbidity.
The study is approved by the Danish National Committee on Health Research Ethics (N-20180074) and the Danish Data Protection Agency (2018-139).

Results
No results are available yet.

Conclusion
Our hypothesis is that the content of total n-3 PUFAs, as well as both marine and plant-based n-3 PUFAs, in adipose tissue is inversely associated with the risk of CKD and its subtypes.