BACKGROUND:Trimethoprim-sulfamethoxazole prophylaxis effectively prevents opportunistic and non-opportunistic infections in kidney transplantation, but optimal duration remains uncertain. This study investigated whether extending TMP-SMX prophylaxis is associated with lower infection rates. METHODS:This target trial emulation using observational data from the Swiss Transplant Cohort Study compared short (< 7 months) versus long (≥ 7 months) TMP-SMX prophylaxis. The primary outcome was bacterial infection potentially susceptible to TMP-SMX up to 12-months post-transplant. Inverse probability weighting (IPW) adjusted for confounders including age, living donation, lymphocyte counts, use of antithymocyte globulin, acute rejection, CMV infection, and transplant center. All bacterial and opportunistic infections, kidney function, and patient and allograft survival were summarized descriptively. RESULTS:A total of 1700 KTRs fulfilled inclusion criteria; 1325 (78%) participants received a short prophylaxis and 375 (22%) received a long prophylaxis. Median TMP-SMX duration was 179 days in the short group and 280 days in the long group. At 12-month post-transplant, the primary outcome was observed in 120/1325 (9.1%) in the short group and 43/375 (11.5%) in the long group. IPW analysis estimated an adjusted risk difference of 2.11% (95% CI -0.47% to 5.27%). Center, rejection, and use of ATG were associated with longer TMP-SMX duration, but risk difference was similar before and after weighting. Urinary tract infection was the most common bacterial infection. Opportunistic and overall infection rates, kidney function, and patient and graft survival were similar among groups. CONCLUSIONS:In this target trial emulation, no differences in bacterial infection rates at 12-month post-transplant was observed between short and long TMP-SMX prophylaxis.

STUDY AIM: Renal biopsies provide important and decisive information for diagnosis and therapy. Although biopsies are considered safe, bleeding complications remain a concern. We analysed the complication rate after kidney biopsies in native and transplant kidneys and their association with platelet function analyser bleeding time (PFA BT) and estimated glomerular filtration rate (eGFR). METHODS: This single-centre observational study included all patients who underwent an ultrasound-guided kidney biopsy at the University Hospital Basel from 2015 to August 2019. The main objective was to investigate the association of PFA BT with significant bleeding complications in kidney biopsies. Significant bleeding was defined as a haemoglobin decrease of >10 g/l within 48 hours or the need for transfusion after bleeding, according to the discretion of the treating physician. The pre-biopsy assessment included bleeding time using PFA BT, INR, thrombocyte count, and eGFR. RESULTS: A total of 819 kidney biopsies—285 native and 534 transplant—were analysed. Complications occurred in 32 biopsies (3.9%): 18 (6.3%) in native and 14 (2.6%) in transplant kidneys. Bleeding was the most frequent complication in both groups. Overall, low eGFR (p = 0.01) and prolonged PFA BT (p = 0.02) were associated with bleeding complications. In native kidney biopsies, inpatient biopsy was associated with bleeding complications (p = 0.005), while in transplant kidney biopsies, bleeding complications were associated with time after transplantation (p <0.001), prolonged PFA BT (p <0.001), and diagnostic biopsies (p = 0.01). In the multivariable model, low eGFR was the only significant factor associated with bleeding complications (odds ratio 3.57, 95% confidence interval 1.76-7.23, p <0.001). CONCLUSIONS: A low eGFR, especially below 30 ml/min, is associated with increased bleeding risk in native and transplant kidney biopsies.

Importance:Surgical site infections (SSIs) are one of the most common health care-associated infections. Surgical site infections can have harmful effects in liver transplant (LT) recipients. Objective:To assess the incidence of SSI after LT and identify risk factors associated with SSIs and whether SSIs are associated with death and graft loss. Design, Setting, and Participants:A multicenter cohort study encompassing data on LT performed at all Swiss transplant centers between May 1, 2008, and September 30, 2020, was conducted. Data analyses were performed in 2023. Exposure:Liver transplant. Main Outcomes and Measures:Frequency of SSIs within 90 days after transplant, risk factors associated with SSIs, and association of SSIs with 1-year death or graft loss. Surgical site infections were defined according to Centers for Disease Control and Prevention criteria with SSIs occurring within 90 days after LT. For association with posttransplant outcomes, 1-year follow-up data were analyzed. Results:Among 1333 LT recipients in the Swiss Transplant Cohort Study, 1158 adults were included in analyses. Median age was 57.2 (IQR, 49.3-62.8) years and 792 were men (68.4%). Seventy patients (6.0%) had an SSI. Most SSIs were deep incisional (9 [12.8%]) or organ-space infections (54 [77.1%]). In most SSIs (56 [80.0%]), bacteria were detected, most frequently Enterococcus spp (36 of 75 [48.0%]) and Escherichia coli (12 of 75 [16.0%]). In multivariable analysis, prior liver transplant (odds ratio [OR] 4.01; 95% CI, 1.44-11.18; P = .008) and living liver donation (OR, 4.08; 95% CI, 1.37-12.16; P = .01) were independent risk factors associated with SSIs. Surgical site infections were independently associated with graft loss and/or death (hazard ratio [HR], 3.24; 95% CI, 1.82-5.79; P < .001); this association was observed in separate analyses on graft loss (HR, 2.97; 95% CI, 1.32-6.68; P = .02) and death (HR, 3.25; 95% CI, 1.44-7.35; P = .01). Conclusions and Relevance:The findings of this study suggest that prior liver transplant and living liver donation are independent risk factors associated with SSIs and that SSIs are independently associated with graft loss and/or death, highlighting the relevance of this health care-associated infection.

INTRODUCTION:We present the case of a 68-year-old patient with acute postrenal kidney failure, without evidence of hydronephrosis on repeated imaging. Diagnosis was complicated by a transient recovery of renal function and concomitant development of severe glomerular proteinuria. The decision to perform a bilateral nephrostomy despite the absence of hydronephrosis was based on the highly suggestive history of a postrenal kidney failure. Following the intervention, there was an immediate resumption of diuresis and complete recovery of the previously dialysis-dependent renal failure.

The interplay of recipient age and graft loss causes is underexplored, despite its relevance for patient management and endpoint definition in clinical trials. This study aimed to investigate the impact of recipient age on graft loss causes. In this retrospective single-center cohort study with 1743 kidney transplantations between 1995 and 2022, graft losses were assigned to either death with graft function (DwGF) or graft failure (GF). Additionally, causes of death and GF were determined by reviewing all available clinical/histological information. Data were analyzed across recipient age groups (≤40, 41–60 and >60 years) and across three time periods (1995–2004, 2005–2014, 2015–2022). Among 816 graft losses, 56% were attributed to DwGF and 44% to GF. The proportion of DwGF increased stepwise with age (21% in young vs. 52% in middle-aged vs. 76% in elderly patients; p < 0.0001), with similar proportions across the three time periods. Rejection alone or in combination with other events caused GF in 76% of young, 51% of middle-aged, and 34% of elderly patients (p < 0.0001). Main death-causes were cardiovascular events (23%), infections (23%) and malignancies (23%). Graft loss causes are strongly age-related. This might have significant implications for clinical study design and patient management.

INTRODUCTION: Currently, approved disease-specific therapies for patients with immunoglobulin (Ig) A nephropathy in Switzerland are scarce. According to the 2024 KDIGO guidelines, current treatments focus on reducing proteinuria and nephron loss using nephroprotective regimens consisting of renin-angiotensin system blockade, the use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and the dual endothelin angiotensin receptor antagonist sparsentan. Systemic glucocorticoids and a targeted-release formulation of budesonide are other therapeutic options to reduce IgA nephropathy-specific drivers of nephron loss. However, their use has been associated with adverse effects, even with targeted-release budesonide, and the benefit of these therapies remains to be weighed against the risk of treatment-emergent toxicity. This highlights the ongoing need to identify more effective and safer therapies for the treatment of IgA nephropathy. In the last few years, increasing understanding of the pathogenetic role of alternative complement pathway dysregulation in the onset and progression of IgA nephropathy has led to the development of new complement-targeting therapies. Iptacopan is an oral inhibitor of complement factor B that effectively blocks the alternative complement pathway. CASE PRESENTATION: We report the successful treatment of a 40-year-old female patient suffering from IgA nephropathy with iptacopan. In this patient, despite maximum tolerated renin-angiotensin system blockade and fully dosed SGLT-2 inhibitor administration, we failed to achieve the desired reduction in proteinuria to <0.5 g/day. Proteinuria persisted at a level of >1 g/day despite the goal of blood pressure ≤120/70 mm Hg being achieved. Impressively, within just two months after the initiation of iptacopan, we noted a reduction in proteinuria to 0.5 g/day, and after nearly six months, we reached our goal, with proteinuria at <0.3 g/day, a value continuing to the present day. Further, the medication was well-tolerated. CONCLUSION: To the best of our knowledge, our case report is the first in Switzerland to show that selective inhibition of the alternative complement pathway in IgA nephropathy results in significant and ongoing reduction of proteinuria after six months of therapy, supporting the innovative concept of targeting the alternative complement pathway with iptacopan to treat IgA nephropathy.

Abstract Background The immunogenicity of the standard influenza vaccine is reduced in solid-organ transplant (SOT) recipients, so new vaccination strategies are needed in this population. Methods Adult SOT recipients from 9 transplant clinics in Switzerland and Spain were enrolled if they were >3 months after transplantation. Patients were randomized (1:1:1) to a MF59-adjuvanted or a high-dose vaccine (intervention), or a standard vaccine (control), with stratification by organ and time from transplant. The primary outcome was vaccine response rate, defined as a ≥4-fold increase of hemagglutination-inhibition titers to at least 1 vaccine strain at 28 days postvaccination. Secondary outcomes included polymerase chain reaction–confirmed influenza and vaccine reactogenicity. Results A total of 619 patients were randomized, 616 received the assigned vaccines, and 598 had serum available for analysis of the primary endpoint (standard, n = 198; MF59-adjuvanted, n = 205; high-dose, n = 195 patients). Vaccine response rates were 42% (84/198) in the standard vaccine group, 60% (122/205) in the MF59-adjuvanted vaccine group, and 66% (129/195) in the high-dose vaccine group (difference in intervention vaccines vs standard vaccine, 0.20; 97.5% confidence interval [CI], .12–1); P < .001; difference in high-dose vs standard vaccine, 0.24 [95% CI, .16–1]; P < .001; difference in MF59-adjuvanted vs standard vaccine, 0.17 [97.5% CI, .08–1]; P < .001). Influenza occurred in 6% of the standard, 5% in the MF59-adjuvanted, and 7% in the high-dose vaccine groups. Vaccine-related adverse events occurred more frequently in the intervention vaccine groups, but most of the events were mild. Conclusions In SOT recipients, use of an MF59-adjuvanted or a high-dose influenza vaccine was safe and resulted in a higher vaccine response rate. Clinical Trials Registration Clinicaltrials.gov NCT03699839.

Several molecular mismatch assessment approaches exist, but data on their combined use are limited. In this study, we aimed to define distinct risk groups for rejection based on the combination of three molecular mismatch assessment approaches (i.e., eplet mismatch count, the number of highly immunogenic eplets and PIRCHE-II score) in 439 consecutive immunological standard risk transplantations. For each molecular mismatch assessment approach, ROC analyses were used to define cut-offs for prediction of (sub) clinical rejection according to Banff 2019 classification within the first year post-transplant as a reference. If all three scores were below the cut-off, the patient was assigned to the low-risk group (19% of patients); if all three scores were above the cut-off, the patient was assigned to the high-risk group (21% of patients). The one-year incidence of (sub) clinical rejection was 12% in the low-risk group and 33% in the high-risk group (p = 0.003). Internal validation of the assigned risk groups for prediction of other outcomes revealed a high consistency: clinical rejection (6% vs. 24%; p = 0.004), ATG-treated rejection (1% vs. 16%; p < 0.001) and development of de novo HLA-DSA at 5 years post-transplant (6% vs. 25%; p = 0.003). The molecular mismatch risk group was an independent predictor for (sub) clinical rejection (high-risk vs. low-risk: hazard ratio 3.11 [95%-CI 1.50-6.45]; p = 0.002). We conclude that combining molecular mismatch approaches allows us to distinguish low- and high-risk groups among standard renal allograft recipients. Independent validation in other patient populations and different ethnicities is required.

Abstract Background/objectives Shock and accompanying acute kidney injury (AKI) as a frequent complication is a well-known cause of morbidity and mortality worldwide. The current standard parameters to guide fluid resuscitation therapy (i.e., cardiac output, heart rate, blood pressure, central venous pressure) to avoid AKI and renal replacement therapy remain imprecise, and fluid overload with consequent organ oedema and high intestinal pressures result in further complications. The VoluKid study investigated additional non-invasive fluid volume parameters including assessment of total body water (TBW), renal vascular resistance [renal resistive index (RRI)], intra-abdominal pressure (IAP) and microcirculatory blood flow (MBF) to predict AKI during the first 72 h of intensive care therapy. Methods, design and analysis This mono-centre observational cohort study included patients with shock who presented to the intensive care unit (ICU). Routine volume resuscitation parameters (i.e., cardiac output, heart rate, blood pressure, central venous pressure) were used to guide fluid therapy. In addition, four parameters, including MBF using sublingual incident dark-field microscopy, IAP, RRI assessed by duplex-sonography, and TBW using bioimpedance analysis (BIA), were measured daily and evaluated for predicting the primary outcome of acute kidney injury (AKI) and need for renal replacement therapy within the first 72 h of admission. Baseline and post-ICU admission values of these parameters were compared between patients with and without AKI. Results A total of 45 patients were enrolled in this study. Of those 45 patients, 37 could be followed for the entire study period of 72 h and 14 patients developed AKI (31.1%). Twelve patients (26.7%) had pre-existing renal impairment, one of whom died during the observation period. Nineteen patients (42.2%) had no renal impairment. RRI and IAP did not differ between patients with AKI and without AKI and did not predict AKI. TBW measured by BIA predicted AKI (p = 0.029). After adjustment for covariates (age, body mass index,and gender) this prediction was not significant [adjusted odds rato (OR) 0.99, p = 0.258, 95% confidence interval (CI) [0.97,1.01]]. MBF could not be estimated due a high number of missing values. Conclusions Based on our limited data, none of the non-invasive parameters (TBA, IAP, RRI,) serve as predictors for AKI when assessed during the first 72 h after ICU admission, either when analysed separately or in combination. Registration ClinicalTrials.gov Identifier: NCT02666404, registered 28/01/2016; URL: https://classic.clinicaltrials.gov/ct2/show/NCT02666404.

Surgical site infections (SSIs) are common health care -associated infections. SSIs after kidney transplantation (K -Tx) can endanger patient and allograft survival. Multicenter studies on this early posttransplant complication are scarce. We analyzed consecutive adult K -Tx recipients enrolled in the Swiss Transplant Cohort Study who received a K -Tx be- tween May 2008 and September 2020. All data were prospectively collected with the exception of the categorization of SSI which was performed retrospectively according to the Centers for Disease Control and Prevention criteria. A total of 58 out of 3059 (1.9%) K -Tx recipients were affected by SSIs. Deep incisional (15, 25.9%) and organ/space infections (34, 58.6%) predominated. In the majority of SSIs (52, 89.6%), bacteria were detected, most frequently Escherichia coli (15, 28.9%), Enterococcus spp. (14, 26.9%), and coagulase-negative staphylococci (13, 25.0%). A BMI >25 kg/m(2) (multivariable OR 2.16, 95% CI 1.07-4.34, P = .023) and delayed graft function (multivariable OR 2.88, 95% CI 1.56-5.34, P = .001) were independent risk factors for SSI. In Cox proportional hazard models, SSI was independently associated with graft loss (multivariable HR 3.75, 95% CI 1.35-10.38, P = .011). In conclusion, SSI was a rare complication after K -Tx. BMI >25 kg/ m(2) and delayed graft function were independent risk factors. SSIs were independently associated with graft loss.

Since the implementation of universal antiretroviral therapy, kidney transplantation (K-Tx) has become a valuable option for treatment of end-stage kidney disease for people with HIV (PWH) with similar patient and graft survival as compared to HIV-uninfected patients. Little is known about the hazards and manifestations of infectious disease (ID) events occurring in kidney transplant recipients with HIV. Using linked information collected in the Swiss HIV Cohort Study (SHCS) and the Swiss Transplant Cohort Study (STCS), we described in-depth demographical and clinical characteristics of PWH who received a K-Tx since 2008. Further, we performed recurrent time to event analyses to understand whether HIV was an independent risk factor for ID events. Overall, 24 PWH with 57 ID events were included in this study (100

Introduction: Nowadays, there is insufficient evidence for the recommendation of management patients with a primary membranoproliferative glomerulonephritis (MPGN). A better understanding of the pathogenesis has led to the reclassification of primary MPGN and distinction into the two main entities of either primary immune complex-MPGN or C3 glomerulopathy. Both entities share overlapping pathophysiological features with complement alternative pathway (AP) dysregulation. Iptacopan is an oral inhibitor of the complement factor B that effectively blocks the complement AP. Case Presentation: We report the first successful treatment of a 47-year-old man suffering from a primary immune complex-MPGN with iptacopan. So far established immunosuppressive therapies with prednisone and mycophenolate mofetil failed to control the current flare of the disease, mainly presenting with impaired kidney function and proteinuria within the nephrotic range. However, 3 months after starting the treatment with iptacopan urine protein-creatinine ratio decreased impressively to a level of 100–150 mg/mmol. Thereafter, low-level proteinuria and kidney function remained stable during follow-up. Do date, the treatment with iptacopan is continued as a monotherapy and is well tolerated. Conclusion: To the best of our knowledge, this is the first case report which suggests that iptacopan may be an interesting treatment option for primary immune complex-MPGN.

BackgroundEnterobacterales are often responsible for urinary tract infection (UTI) in kidney transplant recipients. Among these, Escherichia coli or Klebsiella species producing extended-spectrum beta-lactamase (ESBL) are emerging. However, there are only scarce data on frequency and impact of ESBL-UTI on transplant outcomes.MethodsWe investigated frequency and impact of first-year UTI events with ESBL Escherichia coli and/or Klebsiella species in a prospective multicenter cohort consisting of 1,482 kidney transplants performed between 2012 and 2017, focusing only on 389 kidney transplants having at least one UTI with Escherichia coli and/or Klebsiella species. The cohort had a median follow-up of four years.ResultsIn total, 139/825 (17%) first-year UTI events in 69/389 (18%) transplant recipients were caused by ESBL-producing strains. Both UTI phenotypes and proportion among all UTI events over time were not different compared with UTI caused by non-ESBL-producing strains. However, hospitalizations in UTI with ESBL-producing strains were more often observed (39% versus 26%, p = 0.04). Transplant recipients with first-year UTI events with an ESBL-producing strain had more frequently recurrent UTI (33% versus 18%, p = 0.02) but there was no significant difference in one-year kidney function as well as longer-term graft and patient survival between patients with and without ESBL-UTI.ConclusionFirst-year UTI events with ESBL-producing Escherichia coli and/or Klebsiella species are associated with a higher need for hospitalization but do neither impact allograft function nor allograft and patient survival.

BACKGROUND:Urine CXCL10 is a biomarker for renal allograft inflammation induced by rejection, urinary tract infection, or BK polyomavirus (BKPyV) replication. This study aimed to compare urine CXCL10 levels in different stages of BKPyV reactivation and to investigate urine CXCL10 as a biomarker for BKPyV replication.METHODS:We included 763 urine samples (235 patients) from an interventional, randomized trial obtained in the context of regular screening for urine CXCL10 levels. All urine samples had a complete urine sediment analysis, no rejection episode noted within 30 d before urine collection, and a urine decoy cell analysis was conducted within ±3 d.RESULTS:Urine CXCL10 levels were 2.31 ng/mmol in samples without BKPyV viruria, slightly rose to 4.35 ng/mmol with BKPyV viruria, and then markedly increased to 16.42 ng/mmol when decoy cells were detectable, but still in the absence of BKPyV DNAemia ( P  < 0.001). The highest urine CXCL10 values were observed in samples with BKPyV DNAemia (median 42.59 ng/mmol). The area under the curve of urine CXCL10 levels to detect ≥3 decoy cells was 0.816. At a CXCL10 cutoff of 3 ng/mmol, the negative predictive value was 97%. The area under the curve of urine CXCL10 levels to detect BKPyV DNAemia was 0.882, with a negative predictive value of 99% at a CXCL10 cutoff of 3 ng/mmol.CONCLUSIONS:Urine CXCL10 levels are already significantly elevated in BKPyV viruria (especially with decoy cell shedding) and further increase with BKPyV DNAemia. Low urine CXCL10 values can rule out the presence of ≥3 decoy cells and BKPyV DNAemia with high certainty.

BACKGROUND:Addressing the current demographic development, the efficacy and safety of kidney transplantations from very senior donors needs to be carefully evaluated. The aim of this study was to analyse patient and graft outcomes of kidney allograft recipients stratified by donor age.METHODS:We retrospectively investigated n = 491 patients from a prospective, observational renal transplant cohort. Patients with kidneys from very old donors (n = 75, aged >70 years), elderly donors (n = 158, between 60-70 years), and regular donors (n = 258, aged <60 years) were investigated. The primary outcome was death-censored graft survival within the predefined donor age groups.RESULTS:Overall, n = 57 death-censored graft losses occurred. Graft loss was proportionally highest in the very old donor group (n = 11/75), but this did not reach statistical significance when compared to the elderly (14/158) and regular donor groups (32/258); (p = 0.37). Kaplan-Meier analysis demonstrated that 3-year/5-year death-censored graft survival in the very old donor group was 96%/86% and did not differ from the other age groups (p = 0.44). Median estimated glomerular filtration rate (eGFR), calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (in ml/min/1.73 m2 of body surface) 12 months post-transplant did not differ between the elderly donor and very old donor groups (p = 0.53). However, patients who received regular donor kidneys had higher median eGFR compared to recipients in both the elderly and very old donor groups (p <0.0001). During follow-up, 31% of patients developed at least one acute rejection episode. Time-to-event analysis demonstrated no difference in occurrence of any acute rejection event across all three groups (p = 0.11).CONCLUSIONS:This study demonstrates that kidney transplantation from carefully selected very old donors seems a valid option with reasonable short- and mid-term outcomes.

Abstract Study objective: Shock develops in one third of ICU patients. Uncertainty remains about the ideal amount and choice of resuscitation fluid to avoid consequences of fluid overload. Design: The BaSES (Basel Starch Evaluation in Sepsis) Trial is an investigator-initiated, single-centre, randomised controlled clinical trial on volume resuscitation. Setting: We investigated whether volume resuscitation with Hydroxyethyl starch (HES 130/0.4) compared to normal saline (NaCl 0.9%) reduces ICU length of stay. Patients: A total of 244 septic shock patients were randomized (119 to HES, 125 to NaCl). Interventions: Randomization to HES or NaCl for volume resuscitation. Measurements: ICU length of stay (LOS), hospital LOS, ICU mortality, in-hospital mortality, and 1-year mortality, incidence of acute kidney injury (AKI), fluid balance, trajectory of inflammatory parameters, lactate, and SOFA (sequential organ failure assessment) score. Main results: Baseline characteristics and ICU management were comparable among groups. ICU LOS was not significantly shorter with HES (hazard ratio, HR, for ICU discharge alive HES vs. NaCl, 1.11,95% CI 0.83 to 1.49). However, the HES group showed a significantly reduced hospital LOS (HR HES vs. NaCl: 1.48, 95 % CI 1.09 to 2.01, p=0.011). HES did not significantly affect other laboratory values, mortality or renal function. Conclusions: The results of the BaSES trial neither do call for complete suspension of HES from the market, nor do they support a role of HES in volume resuscitation in septic shock. Trial registration: ClinicalTrials.gov Identifier: NCT00273728

Significance Statement This study is the first randomized controlled trial to investigate the clinical utility of a noninvasive monitoring biomarker in renal transplantation. Although urine CXCL10 monitoring could not demonstrate a beneficial effect on 1-year outcomes, the study is a rich source for future design of trials aiming to explore the clinical utility of noninvasive biomarkers. In addition, the study supports the use of urine CXCL10 to assess the inflammatory status of the renal allograft. Background Urine CXCL10 is a promising noninvasive biomarker for detection of renal allograft rejection. The aim of this study was to investigate the clinical utility of renal allograft monitoring by urine CXCL10 in a randomized trial. Methods We stratified 241 patients, 120 into an intervention and 121 into a control arm. In both arms, urine CXCL10 levels were monitored at three specific time points (1, 3, and 6 months post-transplant). In the intervention arm, elevated values triggered performance of an allograft biopsy with therapeutic adaptations according to the result. In the control arm, urine CXCL10 was measured, but the results concealed. The primary outcome was a combined end point at 1-year post-transplant (death-censored graft loss, clinical rejection between month 1 and 1-year, acute rejection in 1-year surveillance biopsy, chronic active T-cell–mediated rejection in 1-year surveillance biopsy, development of de novo donor-specific HLA antibodies, or eGFR <25 ml/min). Results The incidence of the primary outcome was not different between the intervention and the control arm (51% versus 49%; relative risk (RR), 1.04 [95% confidence interval, 0.81 to 1.34]; P = 0.80). When including 175 of 241 (73%) patients in a per-protocol analysis, the incidence of the primary outcome was also not different (55% versus 49%; RR, 1.11 [95% confidence interval, 0.84 to 1.47]; P = 0.54). The incidence of the individual end points was not different as well. Conclusions This study could not demonstrate a beneficial effect of urine CXCL10 monitoring on 1-year outcomes (ClinicalTrials.gov_NCT03140514).