bluuebunny/crossref_metadata_2025_split huggingface dataset:
MO124: Intradialytic Symptomatology is Largely Patient-Specific in both Haemodialysis and Haemodiafiltration: A Randomized Cross-Over Trial between Four Intermittent Dialysis Modalities
Authors: Wijngaarden Gertrude , Rootjes Paul A , de Roij van Zuijdewijn Camiel , Nubé Menso J , Grooteman Muriel 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Standard haemodialysis is associated with a considerable burden of intradialytic symptoms. Although haemodialysis with cool dialysate is associated with less intradialytic discomfort in general, the incidence of cold sensations increases significantly. Whether treatment with online post-dilution high-volume haemodiafiltration [target convection volume (CV) ≥23 L/session] reduces adverse intradialytic symptoms and provokes cold sensations is unknown.

METHOD
We performed a randomized controlled cross-over trial in 40 prevalent dialysis patients, who were subjected to two haemodialysis modalities: standard haemodialysis [sHD; dialysate temperature (Td) of 36.5°C] and cool haemodialysis (cHD; Td 35.5°C) and two haemodiafiltration modalities: low-volume haemodiafiltration (lvHDF, CV 15 L/1.73 m2/session, Td 36.5°C) and high-volume haemodiafiltration (hvHDF, CV ≥23 L/1.73 m2/session, Td 36.5°C). Every dialysis modality lasted 2 weeks. Intradialytic symptoms were evaluated after the last session of each dialysis modality, with a slightly modified Dialysis Symptom Index (mDSI). Intradialytic thermal sensations were scored on the Visual Analogue Scale Thermal Perception (VAS-TP) before and after 1 and 3 h of each treatment session. Patients were trained to use the mDSI and VAS-TP, in order to reduce incidental stress and unwanted learning responses due to the trial environment. Repeated measures analysis of variance (ANOVA) and one-way ANOVA were used to measure potential differences in intradialytic symptoms between the dialysis modalities (intraindividual differences) and to assess potential interindividual differences in intradialytic symptoms. Linear mixed models with an interaction term between time and modality were used to determine differences in rate of change of VAS-TP between the four modalities. When appropriate, stratified models were fitted subsequently.

RESULTS
With the exception of cold sensations during cHD (P = .01), intradialytic symptoms did not differ between modalities, but varied markedly between patients (P &lt; .05 in 11/13 items, Table 1). While the VAS-TP score remained unaltered in sHD, lvHDF and hvHDF, patients felt significantly more cold sensations during cHD (P = .007)(Figure 1). Stratified models showed a decrease of 0.43 points/h on the VAS-TP scale (P = .007) in the first hour of cHD and remained unaltered thereafter [+0.10 points/h (P = .20)]; thermal perception remained unaltered [0.04 points/h (P = .77)] in the other modalities.

CONCLUSION
Intradialytic symptomatology was, except for the symptom feeling cold, by and large similar in all modalities, but it varied markedly between patients. Hence, adverse intradialytic symptoms seem largely patient-specific. Patients experienced more cold sensations during cool HD, but not during haemodiafiltration.
MO154: Enteric Budesonide in IGAN Nephropathy: A Real World Clinical Practice
Authors: López Martínez Marina , Agraz Irene , Bermejo Sheila , Moreso Francesc , Garcia Carro Clara , Alejandra Gabaldón M , Vergara Ander , Ramos Terrada Natalia , Azancot María A , Bolufer Cardona Mónica , Bestard Oriol , José Soler Romeo Maria 
Published: May 2022

Abstract

BACKGROUND AND AIMS
The gut–kidney axis seems to have a principal role in immunoglobulin A nephropathy (IgAN) development [1], leading to new treatment approaches. Enteric budesonide, a glucocorticosteroid that release the active drug in the distal ileum, has proved proteinuria reduction and estimated glomerular filtration rate (eGFR) benefit [1, 2]. Moreover, systemic steroid therapy implies severe adverse events that budesonide seems to avoid [1, 3]. Therefore, we aim to evaluate the effect of budesonide treatment in our cohort of patients affected by IgAN.

METHOD
We retrospectively selected 17 patients, from 19 to 74 years, which were treated with enteric budesonide. All of them, except for a patient with Henoch-Schönlein purpura and microhaematuria, had a renal biopsy-confirmed primary IgAN. Twelve were patients with native kidney disease and five were patients with kidney transplant. Three with native kidney disease were excluded due to the lack of therapeutic compliance. The median dose of budesonide was 9 mg/day for the whole period of treatment. Twelve were already treated with renin-angiotensin system (RAS) blockade, which was continued throughout the follow-up period. During the follow-up (maximum 2 years), creatinine, proteinuria measured as change in urine protein creatinine ratio (UPCR) and haematuria were assessed.

RESULTS
Baseline characteristics are shown in Table 1. Overall, the median reductions of UPCR at 3, 6, 12 and 24 months were of 33.08%, 54.62%, 15.38% and 15.38%, respectively. At 6 months, the median UPCR was reduced from baseline 1.3 g/g [IQ range (25%–75%): –0.58 to –4.22] to 0.59 g/g [IQ range (25%–75%): –0.17 to –0.85], P = .028. The creatinine remained stable at 6 months, with baseline median 1.57 mg/dL [IQ range (25%–75%): –1.03 to to 2.03], and creatinine at 6 months with median 1.42 mg/dL [IQ range (25%–75%): –1.01 to –1.93]. Five patients (35.7%) did not have haematuria when budesonide was started, which remained stable at 6 months. No corticosteroid-related side effects were observed. No differences were found between patients with native disease or transplant kidney.

CONCLUSION
Enteric budesonide reduced proteinuria in patients with IgAN nephropathy. Our results suggest that enteric budesonide may represent a new approach to treatment of IgAN in both patients with native and kidney transplant.
MO178: Renal Function Impairment in Diabetic Patients after Intravitreal Injection of Anti-Vascular endothelial Growth Factor
Authors: Rivero Martínez Marta , Fernandez Maria , Berzal Raquel , Frías González Aida , Cordero Lucia , Gonzalez Celia , Hernandez-Velasco Paul , Gutierrez Eduardo , Pascual Julio , Morales Enrique 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Intravitreal administration of vascular endothelial growth factor (VEGF) inhibitors is the treatment of a wide variety of retinal diseases. Kidney damage caused by systemic administration is widely known. However, there is not enough information in the literature on the renal effect of these drugs after intravitreal injection. The aim of the study is to analyse the effect of intravitreal anti-VEGF on kidney function in diabetic patients.

METHOD
A prospective cohort study of diabetic patients with and without chronic kidney disease (CKD) who received intravitreal anti-VEGF from January 2018 to December 2019. Clinical and analytical parameters were analysed. The follow-up time was 24 months.

RESULTS
We included 45 patients (55.6% male) with a mean age of 74.4 ± 11.5 (50–91) years. Approximately 64.4% of patients had CKD [estimated glomerular filtration rate (eGFR) &lt;60 mL/min]. The types of anti-VEGF used were: bevacizumab 57.8% and ranibizumab 42.2%. The average number of doses administered was 7.6 ± 4.8 (1–22). The initial eGFR was 48.7 ± 25.3 mL/min and the Alb/Cr ratio 145 (49.45) mg/g. A significant decrease in the eGFR was observed at 6, 12 and 24 months (Table 1). There was a significant increase in proteinuria at 12 and 24 months. This drop in eGFR was independent of the presence of CKD, the anti-VEGF type or the number of doses. After the admistration of the first dose, five patients (17.2%) in the CKD group required renal replacement therapy (mean time 22 ± 12 months).

CONCLUSION
A significant decrease in eGFR and an increase in proteinuria are observed after administration of anti-VEGF in diabetic patients. For this reason, a close monitoring of renal function is needed to establish an early diagnosis and management of possible complications.
MO190: Experiences of Being a Living Kidney-Donor-Perceived and Measured Stress Levels before and after Kidney Donation
Authors: Andersson Helen , Lennerling Annette , Eriksson Svensson Maria 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Living kidney donation is the preferred kidney replacement therapy considering graft function and survival rates. To donate a kidney is a life-changing experience, and there is a diverse spectrum of emotions connected to this process. The aim of this study was to investigate kidney donors' perceived and measured stress levels before and after donation. Furthermore, to investigate if the level of perceived stress could be linked to the degree of metabolic stress measured using saliva cortisol, serum glucose and insulin levels.

METHOD
A prospective observational study including 83 patients (46 ± 10.9 years, 63% women), who donated a kidney at Sahlgrenska University Hospital, Gothenburg, during 2009–2010. Three self-rating surveys concerning stress (Everyday Life Stress Scale), vital exhaustion (Maastricht Questionnaire of vital exhaustion) and depressive symptoms (Depressive Mood Scale) were answered on the day before surgery, and then 2 and 6 months after kidney donation (see score details, Table 1). Blood samples of insulin, glucose and saliva cortisol were collected at the same time points. Statistical analyses were carried out to investigate changes over time, potential gender differences, and correlations between laboratory data and survey results.

RESULTS
Kidney donors generally scored low in self-rating stress mean 15.5 and depression symptom scales mean 10.8 pre-donation. The Maastricht's questionnaire showed a trend toward significant gender difference at 2 months; women mean score was 32.1 ± 9.3 and men 35.8 ± 6.9, P = .092. At 6 months, there was a significant gender difference in self-reported vital exhaustion, where women scored higher 36.9 ± 7.1 than men 30.7 ± 11.6; P = .037 and a near significant difference on the Depressive Mood Scale, 12.2 ± 12.5 versus 6.4 ± 8.2 at 6 months; P = .058. No significant difference over time in experienced well-being (Everyday Life Stress Scale) was found, 15.6 ± 8.2 vs 14.3 ± 7.6, P = .554. Data are displayed in detail in Table 1 and Figure 1. No correlations between metabolic stress measured as salivary cortisol (morning, noon and evening) and HOMA-IR, and perceived stress were found.

CONCLUSION
Kidney donors self-reported stress level and depressive symptoms did not change pre-donation to 6 months after donation. However, women reported more feelings of exhaustion and stress than men did at 6 months post-donation. In the future, a more structured psychosocial follow-up of kidney donors after at least 6 months is suggested.
MO209: Baseline Characteristics of Adults Enrolled in the Ongoing Phase 3 Randomized, Double-Blind, Active-Control Trial of Sparsentan For the Treatment of Immunoglobulin A Nephropathy (PROTECT)
Authors: Wong Muh , Barratt Jonathan , Komers Radko , Mercer Alex , Rosenberg Noah 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Immunoglobulin A nephropathy (IgAN) is the most common glomerular disease worldwide. Despite optimized standard of care treatment, up to 40% of individuals with IgAN develop kidney failure requiring dialysis or kidney transplantation, consequently seriously affecting their quality of life and mortality. Treatments that reduce proteinuria and risk of kidney disease progression are urgently needed for IgAN. Sparsentan is a novel Dual Endothelin Angiotensin Receptor Antagonist (DEARA) being investigated for IgAN. The Phase 3 PROTECT study is examining the potential long-term antiproteinuric and nephroprotective potential and safety of sparsentan compared with an active control, angiotensin receptor blocker (ARB) irbesartan, in adults with IgAN. Here we report the baseline characteristics for all patients enrolled in the PROTECT trial.

METHOD
PROTECT is an ongoing, global, Phase 3, multicenter, randomized, double-blind, parallel-group, active controlled study designed to evaluate the efficacy and safety of sparsentan versus the active control irbesartan in adults with IgAN with overt proteinuria despite receiving maximized treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or ARB. The study duration is 270 weeks: a double-blind period of 114 weeks followed by an open-label extension period of up to 156 weeks. The primary efficacy endpoint is the change from baseline in urine protein/creatinine ratio (UP/C) based on a 24-h urine sample at Week 36. Key inclusion and exclusion criteria are shown in Table 1. Patients took their last dose of maximized standard-of-care treatment with ACEi and/or ARB therapy the day before randomization. Patients were randomized 1:1 to sparsentan or irbesartan (target dose 400 and 300 mg/day, respectively), stratified by screening eGFR and urine protein excretion values. The blinded and aggregated baseline characteristics of all the patients enrolled in the PROTECT trial are summarized descriptively.

RESULTS
A total of 406 patients from clinical sites in 18 countries, including sites in North America, Europe and Asia Pacific, were enrolled in PROTECT and 404 patients were included in the primary analysis population. Selected demographic and clinical characteristics are reported in Table 2.

CONCLUSION
PROTECT is the largest interventional trial testing a novel drug to date in IgAN. Patients with IgAN enrolled in the PROTECT trial display demographic and clinical characteristics consistent with those previously reported in the broader high-risk IgAN patient population. The presentation despite implementation of optimized standard of care treatment demonstrates the burden of IgAN and the unmet need for novel therapies in this patient population.
MO211: Variability of Proteinuria in Nephrotic Syndrome: GC1008 PH2 Trial in FSGS
Authors: Lin Julie , Hariri Ali , Accomando Beverly 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Treatment-resistant primary focal segmental glomerulosclerosis (FSGS) is a rare glomerulopathy associated with nephrotic range proteinuria (&gt;3.5 g/24 h). Treatment goals are reduction in proteinuria, which can delay progression to end-stage renal disease. Lack of quality repeated measures data for proteinuria in nephrotic patients is an important methodological limitation in current clinical trials research.

METHOD
We examined the 24-h urine collections (traditionally considered to be the gold standard for proteinuria assessment) compared with average of two consecutive first morning spot urine protein/creatinine (Up/c) ratio results for the patients in the placebo arm (n = 10)of this randomized, double-blind placebo-controlled study (3:3:2 allocation for 1 mg/kg, 4 mg/kg, and placebo treatment groups). Patients received randomized treatment for 112 days and were followed double-blind to 252 days. First morning Up/c was obtained from first morning spot urine collections for all visits; 24-h timed collections were performed for Day 1 and Day 112 visits. For first morning Up/c, the average of two collections at each study time point was used for analysis.

RESULTS
Median age was 42 years, 40% female, 20% black, median eGFR 60 mL/min/1.73 m2 with median Up/c 6.4 g/g (NCT01665391). Correlation coefficient between 24-h timed collection and averaged spot Up/c was r = 0.63 (P = .004). For 24-h timed urines, between subject SD = 2.015 g/24 h and within subject SD = 7.328 g/24 h. For averaged first morning spot Up/c, between subject SD = 2.5 g/g and within subject SD = 2.3 g/g.

CONCLUSION
In clinical trials subjects with nephrotic syndrome from biopsy-proven FSGS on stable doses of ACEi/ARB medications, 24-h timed collections do not provide additional useful data beyond average of two first morning spot Up/c. These data suggest that labour intensive, cumbersome timed 24-h urine collections should not be performed in clinical trials of nephrotic syndrome patients. Importantly, these data should allow for more precise power and sample size estimates for future interventional clinical trials of nephrotic syndrome.
MO214: Health-Related Quality of Life Among Patients With Anca Vasculitis
Authors: Nic an Riogh Eithne , Gogarty Eoin , Reedy Brian , Verrelli Alyssa , Elhassan Elhussein , Scott Jennifer , White Arthur , Little Mark 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a debilitating disease that can have a significant impact on a patient's quality of life. The aim of this study was to assess the longitudinal quality of life amongst those diagnosed with AAV using the EQ-5D instrument, which allows for calculation of quality-adjusted life years (QALYs.)

METHOD
A total of 343 patients with AAV participated in this study, of which 191 (55.7%) were male, resulting in 2746 episodes. The EQ-5D-5L standardised instrument was used to evaluate health-related quality of life in the domains of mobility, self-care, usual activities, pain/discomfort, anxiety/depression and to generate a summary index score. Overall health was also rated using a visual analogue scale (0–100). EQ-5D questionnaires were completed during routine nephrology clinic attendances and through a vasculitis patient support smartphone app. We used a random effects model to control for multiple entries relating to individual patients.

RESULTS
A lower quality of life was seen amongst those with AAV (median index value 0.80, overall population average 0.856). The mean visual analogue scale score was 75.6 ± 17.3 (overall population average 82.8, Fig. 1). Patients’ pain and discomfort level (mean 1.95) was most affected while self-care (mean 1.33) was least affected (Fig. 1). An increase in BVAS tightly correlated with a reduction in quality of life. Using the random effects model, the index score was seen to decrease with increasing age with a 2.7% reduction in index score per decade. A 7% reduction in index score was seen during periods of disease activity compared with periods of remission. Patients with end-stage kidney disease requiring dialysis had an 8% reduction in index score. A reduced quality of life was seen following COVID-19 lockdown with a 5% reduction in index score seen. Using a median survival rate of 6.16 years for patients with small vessel vasculitis, we calculated the QALYs for this population as 4.9 years.

CONCLUSION
We have defined for the first time the EQ-5D index value over the full disease course in patients with AAV. Notably, we have identified a reduction in quality of life during periods of disease activity. Other studies have demonstrated a reduction in quality of life during active disease using the AAV–PRO questionnaire and the Medical Outcomes Study Short Form-36. A decrease in work productivity has also been noted. Previously reported mean index values of 0.72 and 0.76 were lower than our observed values, although both are significantly reduced compared with population norms. In conclusion, this research highlights the negative impact of AAV on patients’ lives.
MO231: Comparison of Dominant and Non-Dominant C3 Deposition in Primary Glomerulonephritis
Authors: Ryu Jiwon , Jun Chin Ho 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Alternative complement pathway (AP) dysregulation plays a key role in glomerulonephritis (GN) and is associated with C3 deposition. Herein, we examined pathological and clinical differences between cases of primary GN with C3-dominant (C3D-GN) and non-dominant (C3ND-GN) deposition.

METHOD
We extracted primary GN data from the Korean GlomeruloNEphritis sTudy (KoGNET). C3D-GN was defined as C3 staining two grades greater than C1q, C4 and immunoglobulin via immunofluorescence analysis. Data between groups were age- and sex-matched (each group, n = 61).

RESULTS
The C3D-GN group exhibited higher serum creatinine (P = .027), greater prevalence of estimated glomerular filtration rates &lt; 60 mL/min/1.72 m2 (P = .009), higher C-reactive protein levels (P = .003) and lower serum C3 levels (P = .018). Serum albumin, urine protein/creatinine ratio, number of patients who progressed to end-stage renal disease and mortality were comparable between groups. Interstitial fibrosis and tubular atrophy were greater in the C3D-GN group (P = .0027 and .005, respectively) than in the non-C3GN group. C3 deposition was dominant in the former group (P &lt; .001), in parallel with increased subendothelial deposition (P = .003).

CONCLUSION
Greater progression of renal injury and inflammation occurred in patients with C3D-GN than with C3ND-GN, potentially owing to AP dysregulation.
MO237: Rituximab in Treatment of Minimal Change Disease and Primary Focal Segmental Glomerulosclerosis in Adults-Single Center Experience
Authors: Zagorec Nikola , Horvatic Ivica , Kasumović Dino , Toric Luka , Šenjug Petar , Galešić Ljubanović Danica , Galesic Kresimir 
Published: May 2022

Abstract

BACKGROUND AND AIMS
Rituximab (RTX) showed some efficacy in treatment of minimal change disease (MCD) and primary focal segmental glomerulosclerosis (pFSGS) [1]. The results of its off-label use and as steroid-sparing agent were especially promising in steroid-dependent, frequently relapsing or steroid-resistant forms of MCD and pFSGS in adults [2].

METHOD
All patients treated with RTX in Department of Nephrology and Dialysis, University Hospital Dubrava, Zagreb, were retrospectively reviewed. Complete remission (CR), steroid-resistant nephrotic syndrome (SRNS), steroid-dependent nephrotic syndrome (SDNS), multidrug-resistant SRNS (MDR-SRNS) and calcineurin inhibitor (CNI)-resistant SRNS were defined according to KDIGO 2021 [3].

RESULTS
Of 82 patients treated with RTX, 11 patients had biopsy proven MCD and pFSGS. Table 1 summarizes relevant demographic, clinical and treatment data. RTX was applied in five patients with SDNS, four patients with MDR-SRNS, one patient with CNI-resistant SRNS and one patient with active hepatitis C and newly onset MCD as a first line therapy. Median follow-up after initial diagnosis and RTX application was 122.9 (range 30–219) and 20 (range 3–117) months, respectively. All patients were initially treated with steroids, and RTX was the drug most commonly applied after treatment with CNI and cyclophosphamide (CYC). Median proteinuria at the time of RTX application was 10 g/day (range 2.5–16.7), 10 patients had preserved kidney function and only 1 patient with collapsing FSGS (case 11) had severe acute kidney injury. Mean cumulative dose of RTX for induction was 1700 mg and short course of steroids was used concomitantly in 10 cases (except case 5). CR was achieved in seven cases (six cases of MCD and one case of MDR-FSGS). Three of seven patients with CR to RTX experienced relapse of disease. Time to relapse was 6, 15 and 40 months in case 5, 3 and 11, respectively. Repeated RTX application led to CR in all three cases. CR persisted in five patients even after the steroids cessation. There were no serious adverse effects of RTX administration in our cohort.

CONCLUSION
RTX showed respectable efficacy in our cohort of adults with SDNS-MCD and in case of MDR collapsing FSGS. Although statistical comparison was not performed because of small number of patients, it seems that RTX is more effective in group of SDNS than MDR-SRNS. In our cohort, patients with relapse of RTX-sensitive disease responded to repeated application. Role of RTX in treatment of MCD and pFSGS should be evaluated in randomized clinical trials.