Nephrology Dialysis Transplantation

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ISSN / EISSN : 0931-0509 / 1460-2385
Published by: Oxford University Press (OUP) (10.1093)
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Markus Ketteler, Andrzej Wiecek, Alexander R Rosenkranz, Claudia Ose, Jan Rekowski, Horst Lorenz, Burkhard Hellmann, Michael Karus, Michaela Ruhmann,
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac206

Abstract:
We previously reported that modified-release nicotinamide (NAMR) was superior to placebo in reducing serum phosphate concentrations over 12 weeks in a large cohort of haemodialysis patients with hyperphosphataemia. Here, we report outcomes after 52 weeks of treatment. NOPHOS was a phase III, international, randomised, controlled, double-blind trial in parallel group design. NAMR (250–1500 mg/d) was investigated in comparison to placebo as an add-on therapy to an individual therapy with approved phosphate binders. In the intention-to-treat population (NAMR: N = 539, placebo: N = 183), serum phosphate was significantly lower in the NAMR group compared to the placebo group at W24 (5.40 ± 1.55 mg/dl vs. 5.79 ± 1.37 mg/dl, P < 0.001) with a mean difference of -0.39 mg/dl [95% CI -0.66, -0.13], but was comparable between the groups at W52 (mean difference -0.08 [95% CI -0.36, 0.20]). In the completer population (N = 358), statistical significance in favour of NAMR was reached at W24 and W52. The treatment effect was reduced in patients with high baseline serum intact parathyroid hormone (iPTH) compared to patients with low baseline serum iPTH. Compliant patients in the NAMR group had a more pronounced and sustained reduction in serum phosphate than non-compliant patients. NAMR treatment was associated with a significantly increased risk of thrombocytopenia, pruritus, anaemia, and diarrhoea. Herpes zoster occurred exclusively in patients randomised to NAMR. NAMR combined with phosphate binders significantly reduced serum phosphate over the first 24 weeks of treatment, but the treatment effect was not maintained up to W52. Non-compliance may have contributed to reduced long-term efficacy. Several newly identified safety signals warrant further evaluation.
Yuko Makita, , Daisuke Nakano, Hiroyuki Yanagawa, Toshiki Kano, , Akira Nishiyama,
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac204

Abstract:
Background: Galactose-deficient IgA1 (Gd-IgA1) plays a crucial role in the development of IgA nephropathy (IgAN). However, the pathological role of Gd-IgA1-containing immune complexes (ICs) and the mechanism of deposition in the mesangial region remain unclear. Methods: To examine deposition of Gd-IgA1-containing ICs in the mesangial region through glomerular endothelial cell injury, we evaluated the alteration of renal microvascular endothelial glycocalyx in nude mice injected with Gd-IgA1-IgG ICs. Human renal glomerular endothelial cells (HRGECs) were used to assess the potential capacity of Gd-IgA1-IgG ICs to activate endothelial cells. Results: Nude mice injected with Gd-IgA1-containing ICs showed podocyte and endothelial cell injuries with IgA, IgG, and C3 depositions in glomerular capillaries and the mesangium. Moreover, albuminuria and hematuria were induced. Real-time glycocalyx imaging showed that renal microvascular glycocalyx was decreased immediately after injection of Gd-IgA1-containing ICs and then mesangial IgA deposition was increased. After coculture of Gd-IgA1-containing ICs with HRGECs, mRNA expression levels of endothelial adhesion molecules and proinflammatory mediators were upregulated significantly. Conclusion: Gd-IgA1-IgG ICs had a high affinity for glomerular endothelial cells, which resulted in glomerular filtration barrier dysfunction mediated by glycocalyx loss. Furthermore, Gd-IgA1-IgG ICs accelerated production of adhesion factors and proinflammatory cytokines in glomerular endothelial cells. The glomerular endothelial cell injury induced by Gd-IgA1-containing ICs may enhance the permeability of immunoglobulins in the mesangial region and subsequent inflammatory responses in the pathogenesis of IgAN.
, Paula Allen-Meares, Ana C Ricardo, Michael J Fischer, Elisa J Gordon, Eunice Carmona-Powell, James Sondheimer, Jing Chen, Edward Horwitz, Xue Wang, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac201

Abstract:
Background: Limited health literacy is associated with significant morbidity and mortality in the general population but the relation of health literacy with long-term clinical outcomes among adults with chronic kidney disease (CKD) is less clear. Methods: Prospective data from the Chronic Renal Insufficiency Cohort (CRIC) Study (n = 3,715) were used. Health literacy was assessed with the Short Test of Functional Health Literacy in Adults (dichotomized as limited/adequate). Cox proportional hazards models were used to separately examine the relations of health literacy with CKD progression, cardiovascular event (any of the following: myocardial infarction, congestive heart failure, stroke, or peripheral artery disease), and all-cause, cardiovascular, and non-cardiovascular mortality. Poisson regression was used to assess the health literacy-hospitalization association. Models were sequentially adjusted: Model 1 adjusted for potential confounders (sociodemographic factors) while Model 2 additionally adjusted for potential mediators (clinical and lifestyle factors) of the associations of interest. Results: In confounder-adjusted models, participants with limited (versus adequate) health literacy (555 [15%]) had an increased risk of CKD progression (Hazard Ratio [HR] = 1.34; 95% CI = 1.06-1.71), cardiovascular event (HR = 1.67; 95% CI = 1.39-2.00), hospitalization (Rate Ratio = 1.33; 95% CI = 1.26-1.40), and all-cause (HR = 1.54; 95% CI = 1.27-1.86), cardiovascular (HR = 2.39; 95% CI = 1.69-3.38), and non-cardiovascular (HR = 1.27; 95% CI = 1.01, 1.60) mortality. Additional adjustments for potential mediators (Model 2), showed similar results except that the relations of health literacy with CKD progression and non-cardiovascular mortality were no longer statistically significant. Conclusions: In the CRIC Study, adults with limited (versus adequate) health literacy had a higher risk for CKD progression, cardiovascular event, hospitalization, and mortality—regardless of adjustment for potential confounders.
Ilaria Gandolfini, Marta Crespo, Rachel Hellemans, , Christophe Mariat, Geir Mjoen, , Licia Peruzzi, Mehmet Sükrü Sever, Bruno Watschinger, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac203

Abstract:
The Omicron variant, which has become the dominant strain of SARS-CoV-2 worldwide, brings new challenges to preventing and controlling infection. Moreover, the widespread implementation of vaccination policies before and after transplantation, and the development of new prophylactic and treatment strategies for coronavirus disease 2019 (COVID-19) over the past 12–18 months, has raised several new issues concerning kidney transplant recipients. In this special report, the ERA working group DESCARTES (Developing Education Science and Care for Renal Transplantation in European States), addresses several questions related to everyday clinical practice concerning kidney transplant recipients and to the assessment of deceased and live kidney donors: what is the current risk of severe disease and of breakthrough infection, the optimal management of immunosuppression in kidney transplant recipients with COVID-19, the role of passive immunization and the efficacy of antiviral drugs in ambulatory patients, the management of drug-to-drug interactions, safety criteria for the use of SARS-CoV-2 positive donors, issues related to the use of T cell depleting agents as induction treatment, and current recommendations for shielding practices.
, Jessica van der Weijden, Robert S Niznik, Aidan F Mullan, Stephan J L Bakker, Stefan P Berger, Ilja M Nolte, Jan-Stephan F Sanders, Gerjan Navis, Andrew D Rule, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac202

Abstract:
One of the challenges in living kidney donor screening is to estimate remaining kidney function after donation. Here we developed a new model to predict post-donation measured GFR from pre-donation serum creatinine, age and sex. In the prospective development cohort (TransplantLines, n = 511) several prediction models were constructed and tested for accuracy, precision, and predictive capacity for short- and long-term post-donation 125I-iothalamate mGFR. The model with optimal performance was further tested in specific high-risk subgroups (pre-donation eGFR < 90 mL/min/1.73m2, a declining 5-year post-donation mGFR slope or age > 65 years), and validated in internal (n = 509) and external (Mayo Clinic, n = 1087) cohorts. In the development cohort, pre-donation eGFR was 86 ± 14 mL/min/1.73m2, and post-donation mGFR 64 ± 11 mL/min/1.73m2. Donors with a pre-donation eGFR ≥ 90 mL/min/1.73m2 (present in 43%) had mean post-donation mGFR of 69 ± 10 mL/min/1.73m2, and 5% of these donors reached an mGFR < 55 mL/min/1.73m2. A model using pre-donation serum creatinine, age and sex performed optimally, predicting mGFR with good accuracy (mean bias 2.56 mL/min/1.73m2, R2 = 0.29, RMSE = 11.61) and precision (bias interquartile range (IQR) 14 mL/min/1.73m2) in the external validation cohort. This model also performed good in donors with pre-donation eGFR < 90 mL/min/1.73m2 (bias 0.35 mL/min/1.73m2 and IQR 10 mL/min/1.73m2), in donors with negative post-donation mGFR slope (bias 4.75 mL/min/1.73m2 and IQR 13 mL/min/1.73m2) and in donors > 65 years (bias 0.003 mL/min/1.73m2 and IQR 9 mL/min/1.73m2). We developed a novel post-donation mGFR prediction model based on pre-donation serum creatinine, age, and sex.
, , Fadi Haidar, Anne Dufey, Sebastian Carballo, Sophie De Seigneux, Patrick Saudan
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac205

Abstract:
Background: Residual kidney function is considered better preserved with incremental haemodialysis (I-HD) or peritoneal dialysis (PD) as compared to conventional thrice-weekly HD (TW-HD) and associated with improved survival. We aimed to describe outcomes of patients initiating dialysis with I-HD, TW-HD or PD. Methods: We conducted a retrospective analysis of a prospectively assembled cohort in a single university centre including all adults initiating dialysis from January 2013 to December 2020. Primary and secondary endpoints were overall survival and hospitalisation days at one year respectively. Results: We included 313 patients with 234 starting on HD (166 TW-HD and 68 I-HD) and 79 on PD. At study end, 10 were still on I-HD while 45 transitioned to TW-HD after a mean duration of 9.8 +/- 9.1 months. Patients who stayed on I-HD were less frequently diabetics (p = 0.007). Mean follow-up was 33.1 +/- 30.8 months during which 124 (39.6%) patients died. Compared to patients on TW-HD, those on I-HD had improved survival (HR 0.49, 95% CI 0.26 to 0.93, p = 0.029), while those on PD had similar survival. Initial KRT modality was not significantly associated with hospitalisation days at one year. Conclusions: I-HD is suitable for selected patients starting dialysis and can be maintained for a significant amount of time before transition to TW-HD, with diabetes being a risk factor. Although hospitalisation days at one year are similar, initiation with I-HD is associated with improved survival as compared to TW-HD or PD. Results of randomized controlled trials are awaited prior to large-scale implementation of I-HD programs.
, Mia Jensen, Boye L Jense, Kasper Bostlund Assersen, Jens P Goetze, , Trine Borup Andersen, Sigriður Olga Magnusdottir, Brian Kloster, Morten Jønler, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac200

Abstract:
Kidney surgery often includes organ ischemia with risk of acute kidney injury. The present study tested if treatment with combined angiotensin II-AT1 receptor and neprilysin blocker Entresto® (LCZ696-sacubitril/valsartan) protects filtration barrier and kidney function after ischemia and partial nephrectomy in pigs. Single kidney glomerular filtration rate (GFR) by technetium-99m-diethylene-triamine-pentaasetate ([99mTc]Tc-DTPA) clearance was validated (n = 6). Next, four groups of pigs were followed for 15 days (n = 24) after: 1) Partial nephrectomy (1/3 right kidney, 60 min ischemia) + Entresto® (49/51 mg/day, n = 8); 2) partial nephrectomy + vehicle (n = 8); 3) sham + Entresto® (49/51 mg/day, n = 4); 4) sham + vehicle (n = 4). GFR, diuresis, and u-albumin were measured at baseline and from each kidney after 15 days. The sum of single kidney GFR (25 ± 6 mL/min, right and 31 ± 7 mL/min, left) accounted for total GFR (56 ± 14 mL/min). Entresto® had no effect on baseline blood pressure, p-creatinine, midregional pro atrial natriuretic peptide (MR-proANP), heart rate, and diuresis. After 15 days, Entresto® increased GFR in the uninjured kidney (+23 ± 6 mL/min, P < 0.05) and reduced albuminuria from both kidneys. In the sham group, plasma MR-proANP was not altered by Entresto®; it increased to similar levels 2 hours after surgery with and without Entresto®. Fractional sodium excretion increased by Entresto®. Kidney histology and kidney injury molecule-1 in cortex tissue were not different. In conclusion, Entresto® protects the filtration barrier and increases the functional adaptive response of the uninjured kidney.
Andras T Deak, Katarina Belić, Anna-Maria Meissl, Katharina Artinger, , Bernd Rechberger, Tobias Niedrist, Wolfgang F Graier, Roland Malli, Helmut Bischof, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac195

Abstract:
Hyperkalemia is a common complication in cardiorenal patients treated with agents interfering with renal potassium (K+) excretion. It frequently leads to discontinuation of potentially life-saving medication, which has increased the importance of K+-monitoring. Non-invasive means to detect hyperkalemia are currently unavailable, but would be of potential use for therapy guidance. The aim of the present study was to assess the analytical performance of genetically-encoded potassium-ion indicators (GEPIIs) in measuring salivary K+ ([K+]Saliva) and to determine whether changes of [K+]Saliva depict those of [K+]Plasma. We conducted this proof-of-concept study: saliva samples from 20 healthy volunteers as well as plasma and saliva from 29 patients on hemodialysis (HD) before and after three consecutive HD treatments were collected. We compared [K+]Saliva as assessed by the gold standard ion-selective electrode (ISE) with GEPII measurements. The Bland-Altmann analysis showed a strong agreement (Bias 0.71; 95% limits of agreement from -2.79 to 4.40) between GEPII and ISE. Before treatment, patients on HD showed significantly higher [K+]Saliva compared to healthy controls (median 37.7 [30.85; 48.46] vs. 23.8 [21.63; 25.23] mmol/L; p < 0.05). [K+]Plasma in HD patients decreased significantly after dialysis. This was paralleled by a significant decrease in [K+]Saliva, and both parameters increased until the subsequent HD session. Despite similar kinetics, we found weak or no correlation between [K+]Plasma and [K+]Saliva. GEPIIs have shown an excellent performance in determining [K+]Saliva. [K+]Plasma and [K+]Saliva exhibited similar kinetics. To determine whether saliva could be a suitable sample type to monitor [K+]Plasma, further testing in future studies are required.
Jennifer B Green, Amy K Mottl, George Bakris, Hiddo J L Heerspink, Johannes F E Mann, Janet B McGill, Masaomi Nangaku, Peter Rossing, Charlie Scott, Alain Gay, et al.
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac198

Abstract:
Background: Despite available interventions, people with type 2 diabetes (T2D) remain at risk of chronic kidney disease (CKD). Finerenone, a potent and selective nonsteroidal mineralocorticoid receptor antagonist, and sodium–glucose co-transporter 2 inhibitors (SGLT2is) can reduce both kidney and cardiovascular risks in people with CKD and T2D. Here we outline the design of a study to investigate whether dual therapy with finerenone and a SGLT2i is superior to either agent alone. Methods: CONFIDENCE (NCT05254002) is a randomized, controlled, double-blind, double-dummy, international, multicentre, three-armed, parallel-group, 7.5–8.5-month, Phase 2 study in approximately 807 adults with T2D, stage 2–3 CKD and a urine albumin-to-creatinine ratio (UACR) from ≥ 300–<5000 mg/g. The primary objective is to demonstrate that 6 months’ dual therapy comprising finerenone and the SGLT2i empagliflozin is superior for reducing albuminuria versus either agent alone. Interventions will be once-daily finerenone 10 mg or 20 mg (target dose) plus empagliflozin 10 mg, or empagliflozin 10 mg alone, or finerenone 10 mg or 20 mg (target dose) alone. Results: The primary outcome is relative change from baseline in UACR among the three groups. Secondary outcomes will further characterize efficacy and safety, including change in eGFR and incident hyperkalaemia. Conclusions: CONFIDENCE is evaluating the safety, tolerability and efficacy of dual use of finerenone and a SGLT2i in adults with CKD and T2D. Should an additive effect be shown, early and efficient intervention with dual finerenone and SGLT2i therapy could slow disease progression and provide long-term benefits for people with CKD and T2D.
, Stephanie Izard, , , Amy Sharma, Vinay Nair
Nephrology Dialysis Transplantation; https://doi.org/10.1093/ndt/gfac196

Abstract:
Background: Recent improvement in treatment and patient survival has opened the eligibility of kidney transplantation for patients who developed end-stage kidney disease (ESKD) from plasma cell dyscrasias (PCD). Data on clinical outcomes in this population is lacking. Methods: We conducted a retrospective study of UNOS/OPTN dataset (2006–2018) to compare patient and graft outcomes of kidney transplant recipients with ESKD due to PCD vs other causes. Results: Among 168 369 first kidney transplant adult recipients, 0.22–0.43% per year had PCD as the cause of ESKD. The PCD group had worse survival than the non-PCD group for both living and deceased donor types, (adjusted hazard ratio [aHR]: 2.24 [95% CI: 1.67, 2.99]) and (aHR: 1.40 [1.08, 1.83), respectively. The PCD group had worse survival than the diabetes group, but only among living donor type (aHR: 1.87 [1.37, 2.53]) vs (aHR: 1.16, [0.89, 1.2]). Graft survival in patients with PCD were worse than non-PCD in both living and deceased donor type (aHR 1.72 [1.91, 2.56], aHR 1.30 [1.03, 1.66]). Patient and graft survival were worse in amyloidosis but not statistically different in multiple myeloma, compared to non-PCD group. Conclusion: The study data is crucial when determining kidney transplant eligibility and when discussing transplant risk in patients with PCD.
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