bluuebunny/crossref_metadata_2025_split huggingface dataset:
#5821 CLINICALLY MEANINGFUL IMPROVEMENT IN QUALITY OF LIFE ACCOMPANIES ITCH RELIEF IN PATIENTS WITH CHRONIC KIDNEY DISEASE ASSOCIATED PRURITUS
Authors: Kraft Leonie , Schaufler Thilo , Ruessmann Despina , Morin Isabelle , Menzaghi Frederique , Wen Warren , Krüger Thilo 
Published: June 2023

Abstract

Background and Aims
The impairing effect of chronic kidney disease-associated pruritus (CKD-aP) on the quality of life (QoL) of patients undergoing haemodialysis (HD) is well-established. The aim of this post-hoc analysis was to assess the impact of itch relief on QoL, as measured by the 5-D itch scale, in patients with CKD-aP enrolled in the Phase 3 KALM-1 and -2 clinical trials. This study also aimed to confirm the use of ≥5-point reduction in 5-D itch scale total score as a threshold for clinically meaningful improvement in itch-related QoL, by comparing to notable improvement on the Patients’ Global Impression of Change (PGI-C) scale.

Method
Data were pooled from 851 patients with moderate-to-severe CKD-aP undergoing HD in the KALM-1 and -2 trials testing difelikefalin vs placebo. Sustained responders were defined as patients who achieved a ≥3-point improvement in the weekly mean 24-hour Worst Itching Intensity Numerical Rating Scale [WI-NRS] score at Week 12 of the study, whereas non-sustained responders were defined as patients that reported a ≥3-point improvement in any week of the study but not at Week 12. Improvements in QoL, as measured by the mean change in 5-D itch scale total score from baseline to Week 12, were compared in sustained responders vs non-sustained responders. Data were analysed by ANCOVA multiple imputation, with a missing-at-random assumption. The mean change in 5-D itch scale total score was analysed in relation to patients’ reporting on the five categories of the PGI-C scale.

Results
In pooled analysis, 305 patients undergoing HD with CKD-aP qualified as sustained responders, whereas 128 patients were non-responders. Reduction in 5-D itch scale total score over 12 weeks was significantly higher in sustained responders compared with non-sustained responders (least squares [LS] mean ±standard error; –7.1±0.2 vs –4.0±0.3, LS mean difference –3.0±0.3, p&lt;0.001) (Figure 1). Greater reductions in 5-D itch scale total score were observed in patients reporting more substantial improvements in PGI-C. Specifically, patients reporting much, or very much, improvement in PGI-C scored ≥5-point reduction on the 5-D itch scale (mean ±standard error; –5.3±0.2 and –8.2±0.3, respectively) (Figure 2).

Conclusion
This study observed a greater improvement in QoL, as measured by the 5-D itch scale total score, in patients with CKD-aP who reported a clinically meaningful reduction in itch, as measured by WI-NRS, at Week 12. These results also support the use of ≥5-point reduction in the 5-D itch scale total score as a threshold for clinically meaningful improvement in the QoL of patients with CKD-aP. As only sustained responders exceeded this threshold, these data suggest that continued treatment of itch may be necessary to maximally improve QoL in these patients.
#5825 REAL WORLD EVALUATION OF SGLT2 INHIBITORS IN PATIENTS WITH DIABETIC NEPHROPATHY AND HEART FAILURE: THE EFFECT ON THE DIASTOLIC DYSFUNCTION
Authors: Xydakis Dimitris , Antonaki Ergini , Tzali Eleni , Liaka Fanouria , Petra Christina , Kostakis Konstantinos , Vardaki Eleftheria 
Published: June 2023

Abstract

Background and Aims
In patients with diabetes mellitus and diabetic nephropathy, a high incidence of left ventricular diastolic dysfunction has been reported by various studies. The objective of this study was to the real world evaluation of the impact of sodium glucose cotransporter type 2 (SGLT2) inhibitors on left ventricular (LV) diastolic function of type 2 diabetes mellitus (T2DM) patients with diabetic nephropathy and heart failure (HF).

Method
We studied patients with Diabetes Mellitus type 2, diabetic nephropathy (eGFR&gt; 30 ml/min/1.73 m2) and stable (at least for 3 months) Heart Failure with reduced ejection fraction. We excluded patients treated with iSGLT2 before the study initiation. Laboratory and Echocardiographic studies (Left Ventricular Ejection Fraction LVEF%, the ratio (E/A), Early diastolic velocity (Em), LV mass index (LVMI)), were performed in all patients at baseline and after 12 months of treatment with dapagliflozin 10 mg/day.

Results
67 patents were included (38/29 M/F, age 68±14.2years), with eGFR 72.5±9.2 ml/min/1.72 m2) at baseline. Mean duration of diabetes was 14.2 ± 7.9 years, and mean HbA1c was 7.9 ± 1.1%. There was a significant increase of LVEF (38.5±8.1% to 43.7±7.4%; p = 0.02). LV Mass Index was decreased from 78 g/m2 to 67 g/m2 (p = 0.01) and there was a significant decrease in E/e′ (11.8 to 9.6 cm/s (p = 0.01). Urinary albumin excretion rate at baseline was 526±233 mg/24H and there was a reduction of 32% at the end of the follow up. Multiple regression analysis showed that reduction in albuminuria was an independent predictive factor for E/e′ changes.

Conclusion
Data from this study showed LV diastolic function as assessed in terms of E/e′ and LVMI had significantly improved 12 months after the initiation of dapagliflozin. Reduction of albuminuria by SGLT2i, is an independent predictive factor for improvement of LV function.
#5879 PILOT MONITORING STUDY IN PATIENTS WITH DIABETIC KIDNEY DISEASE USING NORA APPLICATION
Authors: Gaibor Néstor Toapanta , Sánchez Ester , Guirao Cristina , Román Juan Carlos León , Terrada Natalia Ramos , Vergara Ander , Azancot María A , Agraz Irene , Bermejo Sheila , Montiel Estefania , Molina Carlos , Ribó Marc , Romeo Maria Jose Soler 
Published: June 2023

Abstract

Background and Aims
Diabetic Kidney Disease (DKD) is the most common cause of end-stage chronic kidney disease (CKD), conditioning these patients to a worse renal prognosis and higher cardiovascular mortality and/or requirement for renal replacement therapy. The use of novel information and communication technologies (ICTs) focused on the field of health, may facilitates a better quality of life and disease control in these patients. Our objective is to evaluate the effect of monitoring DKD patients using NORA-app.

Method
Prospective feasibility/validation study of NORA-app in patients with DKD stage G3bA3 or higher, followed in outpatient clinics of a tertiary care hospital. NORA-app is an application for smartphones designed to control risk factors, share educational medical information, communicate via chat with health professionals, increase treatment compliance (Morisky-Green), and collect patient reported outcomes such as anxiety and depression using HADs scale. Clinical-laboratory variables were collected at 3 months and compared to control patients who declined using NORA-app.

Results
From 01/01/2021 to 03/03/2022 the use of NORA-app was offered to 118 patients, 82 accepted and 36 declined (controls). After a mean follow-up period of 6,04 months and at the time of data extraction 71(86.6%) NORA-app patients remain active users, 2 have completed the follow-up at one year and 9 are inactive (3 due to death and 6 due to non-locatable). There were no differences in baseline characteristics including Creatinine [2.1 (1.6-2.4) vs. 1.9 (1.5-2.5)] mg/dL and alb/creat [962 (475-1784) vs. 1036 (560-2183)] mg/gr between Nora and control patients respectively. The therapeutic compliance rate in the NORA-app group was 77%, improving at 90 days to 91%. Patients in the NORA-group showed significantly lower levels of alb/creat than controls (768(411-1971) mg/g Vs 2039 (974-3214) p = 0.047) at 90-day follow-up.

Conclusions
In patients with DKD the use of NORA-app was maintained in the long-term, leading to high levels of treatment compliance, and achieving a better disease control. Our study suggests that the generalized use of ICTs may help in the personalized monitoring of these patients to delay the progression of kidney disease.
#5882 BENEFIT OF LONG-TERM TOLVAPTAN ADMINISTRATION ON KIDNEY DISEASE PROGRESSION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A SINGLE-CENTRE EXPERIENCE
Authors: Filiopoulos Vassilis , Melexopoulou Christina , Kofotolios Ioannis , Stroppou Persia , Vallianou Kalliopi , Athanasopoulou Diamanto , Karavasilis Efstratios , Ntounas Georgios , Efstathopoulos Efstathios , Boletis Ioannis , Marinaki Smaragdi 
Published: June 2023

Abstract

Background and Aims
Tolvaptan introduction in autosomal dominant polycystic kidney disease (ADPKD) treatment has significantly modified kidney disease progression in these patients. The efficacy and safety of tolvaptan in the management of ADPKD has already been demonstrated by TEMPO and REPRISE trials, however studies examining the long-term outcomes are limited. The aim of our study was to evaluate the long-term administration of tolvaptan in patients with ADPKD in our center.

Method
ADPKD patients treated with tolvaptan for at least one year were included in the study. Demographic, laboratory, and total kidney volume (TKV) data were collected. Kidney disease progression was assessed by comparing observed and predicted glomerular filtration rate (eGFR), based on the Mayo Clinic prediction model, at the last visit.

Results
Forty-one patients, 22 males, with ADPKD were studied. Median age at initial visit was 35 years (IQR 27-42), and median time on tolvaptan treatment was 24 months (IQR 18-33). Six (14.6%) patients discontinued tolvaptan after at least one year on treatment. Patients were classified according to the Mayo Clinic imaging classification into 1C (n = 8), 1D (n = 16) and 1E (n = 17). Those who received tolvaptan showed a lower eGFR decline from baseline compared to predicted (eGFR 66.7±32.7 vs 61.5±29.1, p&lt;0.001), while a greater benefit was observed in Class 1E (eGFR 60.1±36.5 vs 52.4±29.5, p = 0.003) and in patients with eGFR&gt;45ml/min (eGFR 79.4±28.8 vs 73±25.2, p = 0.001).

Conclusion
Our initial experience from long-term administration of tolvaptan in patients with ADPKD demonstrates benefit on kidney disease progression. The widespread use of tolvaptan in a larger number of patients and their long-term follow up are necessary to draw more secure conclusions.
#5890 THE IMPACT OF CKD STATUS BEFORE KIDNEY TRANSPLANTION ON ALPHATORQUEVIRUS DNA LEVELS
Authors: Lozano Claudia Yuste , González-García Celia , Espada Paula Jara Caro , Hernandez-Velasco Paul , Gayo Lucia Rodriguez , Fernandez Natalia Inmaculada Polanco , Belmonte Amado Andrés , Morales Enrique , Fernandez Mario 
Published: June 2023

Abstract

Background and Aims
Torque teno virus (TTV) is a non-pathogenic anellovirus whose replication kinetics reflects the overall state of immunosuppression. Although chronic kidney disease (CKD) induces a well-stabilised dysfunction of the immune system, long-term use of renal replacement therapies (RRT) itself could also modify the immune response.

Method
We analyzed TTV DNA loads at baseline (in the pre-transplant assessment), day 7 and months 1, 3,6 and 12 after kidney transplantation (KT). Recipients were categorized according to their RRT status: pre-emptive KT (pre-KT), hemodialysis (HD) and peritoneal dialysis (PD). TTV DNA load was measured by real-time polymerase chain reaction.

Results
A total of 221 CKD patients were analyzed. The mean age was 53.9 ± 15.7 years, 72.4% were males, and hypertension (85.1%) and diabetes (30.1%) were the most common comorbidities. According to the pre-transplant TTR status, 159 (72.0%) were on HD, 35 (15.8%) on PD and 27 (12.2%) received pre-KT. There were no differences in baseline comorbidities or age between patients according to their RRT status, except for residual diuresis (P &lt;0.01). HD patients had higher serum albumin levels than patients receiving pre-KT or PD (4.4 ± 0.5 vs. 4.1 ± 0.6 vs. 3.9 ± 0.4 g/dL, respectively, P &lt;0.01). PD patients exhibited higher TTV DNA load (3.4 ±1.2 log10 copies/mL) than HD (2.8 ± 1.6 log10 copies/mL) or pre-KT patients (2.4 ± 2.1 log10 copies/mL), although the differences were not statistically significant. PD patients had lower time on dialysis than HD patients (18.4± 16.2 vs. 37.5± 53.6 months, respectively; P = 0.038). Although PD patients had higher TTV DNA load during the post-transplant follow-up than HD and pre-KT patients, viral kinetics were comparable across these three groups by month 12 after transplantation. Time on dialysis was not associated with TTV DNA load (P = 0.18). RRT status was not associated with the incidence of post-transplant infection or a composite of opportunistic infection and/or de novo malignancy.

Conclusion
TTV DNA load could be useful identifying KT recipients at high risk of immunosuppression-related complications. Although PD patients presented a non-significant higher TTV DNA load, we did not find differences according to the modality of prior RRT or the time on dialysis.
#5895 HOSPITAL-ACQUIRED INFECTIONS IN HOSPITALIZED PATIENTS WITH ACUTE KIDNEY INJURY: A RETROSPECTIVE COHORT STUDY
Authors: Reggiani Francesco , Calatroni Marta , Angelini Claudio , Badalamenti Salvatore 
Published: June 2023

Abstract

Background and Aims
Acute kidney injury (AKI) is recognized as a systemic disease that leads to several complications, including infections. However, only few studies have investigated the relationship between AKI and subsequent development of hospital-acquired infections (HAI). The aim of this study was to evaluate this relationship.

Method
Retrospective cohort study, analyzing data of 413 hospitalized adult patients. Immunosuppressed patients have been excluded. Descriptive analysis was done with t-test, Mann-Whitney and Fisher test. Mediation analysis was done modelling time-to-HAI through a Cox regression, including AKI as the exposure of interest, the use of medical devices as mediator, and age, diabetes and multimorbidity as confounders.

Results
Clinical characteristics of patients are shown in Table 1. AKI patients resulted more fragile and with a higher frequency of HAI (10.8% vs 5.9%, p = 0.07). Univariate logistic regression showed that the presence of urinary catheter (OR 5.053, 95% CI 2.040-12.520) and a longer hospital stay (OR 1.115, 95% CI 1.075-1.157) were risk factors for the development of HAI. Compared to other AKI etiologies, intrinsic AKI had a significantly higher frequency of HAI (38.5%, p&lt;0.01) (Fig. 1). HAI frequency also increased progressively with increasing AKI stage (15.2% in stage I-II and 6.4% patients without AKI or stage I, p = 0.01) (Fig. 1). From the Cox regression model, none of the variables showed an independent association with HAI (Table 2). The total effect of AKI on HAI development was estimated in a HR of 0.970 (95% CI 0.438-3.016). Part of this effect was found to be mediated by the medical devices (HR 1.155, 95% CI 0.982-1.393), while the direct effect of AKI was a HR of 0.840 (95% CI 0.352-2.411).

Conclusion
AKI patients are more fragile and have a higher frequency of HAIs, especially in intrinsic and stage II-III AKI. However, we didn't observe an independent effect of AKI on the development of HAIs. Further research is needed.
#5906 THE PROGNOSTIC VALUE OF DIFFERENT HISTOPATHOLOGIC MODELS OF ANCA-ASSOCIATED VASCULITIDES: A PROSPECTIVE STUDY
Authors: Christodoulou Michalis , Moysidou Eleni , Lioulios Georgios , Stai Stamatia , Bantis Konstantinos , Nikolaidou Christina , Fylaktou Asimina , Papagianni Aikaterini , Stangou Maria 
Published: June 2023

Abstract

Background and Aims
Renal histology in ANCA-associated vasculitides-glomerulonephritis (AAV/GN) is characterized by active (inflammation, necrosis, crescents) and chronic lesions (sclerosis, fibrosis), and lately classified by Berden Classification (BC), ANCA renal risk (RRS) and Mayo Chronicity score (MCCS). We aimed to prospectively compare predictive ability of the three classification models in AVV.

Method
27 AVV/GN patients, 17 females, were estimated at time of diagnosis (T0), based on renal biopsy, commenced on the same treatment protocol, cyclophosphamide+steroids, and followed for 6 months. BC, RRS and MCCS Classification models were initially applied on renal biopsies and results were correlated to renal function at T0, and accordingly, 3 (T3) and 6 (T6) months.

Results
Patients’ median age at presentation was 61.9(18-82) years, ratio of MPO/PR3/ANCA- was 17/7/3, eGFR was 19(19)mg/ml/1.73m2, and 11/27(40.7%) patients were hemodialysis-dependent (HD) at T0. Based to BC model, 5(18,5%), 9(33,3%), 8(29,7%), 5(18,5%) were classified as Focal, Crescentic, Mixed, Sclerotic, respectively, while according to RRS 7(26%), 10(37%), 10(37%) as Low, Medium, High, respectively and to MCCS 3(11%), 13(48%), 6(22%), 5(19%) as Minimal, Mild, Moderate, Severe, respectively. During follow up eGFR significantly increased from T0 towards T3 and T6, 19(19), 34(21), 38.5(26)mg/ml/1.73m2, respectively, p&lt;0.0001. In RRS model, significant improvement was noticed in patients classified as low, eGFR from 37.5(55) vs. 57.5(39) vs. 57(22)mg/ml/1.73m2, p = 0.019) or medium risk group, 31(24) vs. 39(18) vs. 40(10)mg/ml/1.73m2, p = 0.047), at T0, T3, T6, respectively. In BC, a significant increase of eGFR was evident in sclerotic class, 18(9) vs. 32(17) vs. 38(21)mg/ml/1.73m2, respectively p = 0.05. RRS showed important results regarding HD dependence. At T0, from the 11 HD patients 1/3/7 were classified as low/medium/high risk, p = 0.04, the ratio changed to 0/1/5, respectively, p = 0.02 at T3 and 0/1/4, p = 0.04 at T6. No patient with low risk RRS remained on HD, while, 7/10 patients with high RRS, were still on HD at T6. BC and MCCS could not predict end stage renal function either at 3 or 6 months of follow up.

Conclusion
In the short term follow up, ANCA renal risk could better predict renal function outcome compared to Berden Classification and Mayo Chronicity Score, with high RRS frequently leading to HD. Instead, the sclerotic class in BC was not predictive of poor outcome.
#5922 CINACALCET IMPACT ON ESTIMATED GLOMERULAR FILTRATION RATE AMONG KIDNEY TRANSPLANT RECIPIENTS WITH SECONDARY HYPERPARATHYROIDISM: A CASE-CONTROL STUDY
Authors: Yu Jerome Han Yee , Goronflot Thomas , Kerleau Clarisse , Giral Magali , Frey Samuel , Figueres Lucile 
Published: June 2023

Abstract

Background and Aims
Secondary hyperparathyroidism (sHPT) is common in kidney transplant recipients. It remains unknown if Calcimimetic agents (as cinacalcet), oftenly used in this context, have an impact on mortality or morbidity. The objective of this work was to compare the renal and cardiovascular outcome of kidney transplanted patients with sHPT.

Method
Data from January 2008 to December 2019 were retrospectively extracted from the DIVAT database. 575 kidney transplant recipients with sHPT (PTH &gt; 100 pg/ml) followed in Nantes University Hospital, were separated into two groups: Treated (cinacalcet) and sHPT Controls (no cinacalcet). A propensity score was used to match the patients (age, sex, first transplant, transplantation before/after 2015, time on dialysis, history of cardiovascular disease, initial condition, anti-HLA class I and II immunization, corticosteroids, serum parathormone level). Biological data (including estimated glomerular filtration rate by CKD-Epi formula), cardiovascular events (coronaropathy, obliterating arteriopathy of the lower limbs, stroke), return in dialysis or related death were extracted from one year of transplantation to the last follow-up. Time-varying exposure Cox PH model was used.

Results
292 patients were included after matching (146 Treated, 146 sHPT Controls). After one year of transplantation, serum parathormone was significantly higher in Treated patients compared to sHPT Controls (152 pg/mL vs 111 pg/mL respectively, p &lt; 0.001), suggesting a more severe sHPT in Treated patients. 7% of Treated and 10% of sHPT Controls suffered from a cardiovascular event or related death during the follow up (HR = 1.28 [0.52; 3.14], p = 0.6). Return to dialysis or related death were more frequent in the Treated patients (HR: 1.90 [0.97 - 3.75, p = 0.06]. At 48 months post-transplantation, estimated glomerular filtration rate was significantly decreased in Treated patients compared to sHPT controls (52.3 mL/min/1.73 m2 vs 44.1, p = 0.006).

Conclusion
Our study highlights that kidney transplant recipients with sHPT treated with cinacalcet have a worse kidney graft outcome than non-treated sHPT patients. It remains to be assessed if this reflects an underlying more severe sHPT condition or a direct effect of cinacalcet on the graft function. This study needs to be completed by the assessment of bone mineralization. Parathyroidectomy for sHPT should be discussed in kidney transplant recipients with impaired glomerular filtration rate and/or cardiovascular events.
#5950 MAJOR HLA ALLELE AND HAPLOTYPE FREQUENCIES IN THE MALTESE KIDNEY TRANSPLANT REGISTRY
Authors: Micallef Sarah , Buttigieg Jesmar 
Published: June 2023

Abstract

Background and Aims
The human leukocyte antigens (HLA) are the most diverse and polymorphic genes in the human genome and matching them is of vital importance for maximising the survival of kidney transplants. The Maltese archipelago consists of three inhabited islands in the Mediterranean Sea, with a total population of just over half a million people. HLA polymorphisms in Malta have never been described. The aim of this study was to investigate allelic frequencies and determine the most common haplotypes for major HLA Class I and Class II groups in the Maltese kidney transplant registry. This will hopefully facilitate organ sharing with other European countries and improve the HLA matching for kidney transplant recipients.

Method
All patients of Maltese ethnicity on the national kidney transplant list between 2018 and 2022 were analysed retrospectively. HLA typing is routinely performed at medium to high resolution using polymerase chain reaction sequence specific oligonucleotide probes and Luminex technology at the HLA-A, HLA-B, HLA-C, HLA-DR, HLA-DQ and HLA-DP loci. Allele and haplotype frequencies were calculated by direct counting and simple percentages.

Results
A total of 191 patient samples were analysed yielding the following allele types: 16 HLA-A, 31 HLA-B, 17 HLA-C, 15 HLA-DRB1, 6 HLA-DP, 7 HLA-DQ, 5 HLA-DRB3, one HLA-DRB4 and one HLA DRB5. The most frequent allele groups for the HLA-A locus were HLA-A*02 (30.9%), HLA-A*24 (12.0%) and HLA-A*01 (11.8%) whilst for the HLA-B locus these were HLA-B*35 (16.2%), HLA-B*18 (11.5%) and HLA-B*51 (7.1%). The most prevalent allele groups for the HLA-DRB1 locus were HLA-DRB1*11 (24.1%), HLA-DRB1*04 (13.1%) and HLA-DRB1*07 (11.3%). The commonest allele group for each of HLA-C, HLA-DP and HLA-DR loci were HLA-C*07 (23.6%), HLA-DP4 (5.8%), HLA-DQ7 (31.2%) respectively. The five most frequently encountered haplotypes were HLA-A*02-B*13-DRB1*07 (2.1%), HLA-A*02-B*35-DRB1*04 (1.6%), HLA-A*02-B*18-DRB1*10 (1.3%), HLA-A*02-B*35-DRB1*11 (1.3%), HLA-A*24-B*35-DRB1*11 (1.3%).

Conclusion
This study provides the first data on the Major HLA allele and haplotype frequencies in Maltese kidney transplant candidates. Such data may be crucial in setting up international kidney exchange programmes.