The latest medical research on Nephrology
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Request AccessReliability of Glomerular Filtration Rate Estimated by Creatinine-Based Formulas in Moderate to Severe Proteinuria.
Clinical Journal of the AmericanCreatinine-based Glomerular Filtration rate (GFR) formulas introduce a substantial bias in GFR estimations in patients with frank nephrotic syndrome. The bias and accuracy of creatinine-based GFR estimates (eGFR) in patients with non-nephrotic proteinuria need better characterization.
We utilized data from the Ramipril in non-diabetic renal failure (REIN 1) and REIN 2 trials involving non-diabetic chronic kidney disease (CKD) patients with proteinuria to compare eGFRs derived from the CKD Epidemiology Consortium (CKD-EPI)formulas (with and without race), and the European Kidney Function Consortium (EKFC) equations with iohexol clearance (a gold-standard GFR measure, measured glomerular filtration rate [mGFR]). Bias was defined as the median difference between eGFR and mGFR, while accuracy was assessed using P30 and P15 metrics, which represent the percentage of eGFR values within ±30% and ±15% of mGFR, respectively.
The median bias of the three formulas being compared did not differ, being minimal and in a strict range (0.04 to 0.05 ml/ml/min/1.73m2) in the REIN 1 study and (-0.04 to -0.03 ml/min/1.73 m2) in the REIN 2 study. These findings were confirmed in analyses stratified by age and mGFR. The global accuracy of the three formulas regarding P30% showed sufficient accuracy (P30 >75%) in REIN 1 and all strata in REIN 2, but the mGFR stratum <15 ml/min/1.73m2.
The CKD-EPI (with and without race), and EKFC equations show no significant bias and sufficient accuracy in patients with proteinuria. These formulas can be safely applied to non-diabetic CKD patients with moderate to severe proteinuria.
Proteomic Analysis Uncovers Multi-Protein Signatures Associated with Early Diabetic Kidney Disease in Youth with Type 2 Diabetes Mellitus.
Clinical Journal of the AmericanThe onset of diabetic kidney disease (DKD) in youth with type 2 diabetes mellitus often occurs early, leading to complications in young adulthood. Risk biomarkers associated with the early onset of DKD are urgently needed in youth with type 2 diabetes.
We conducted an in-depth analysis of 6596 proteins (SomaScan 7K) in 374 baseline plasma samples from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study to identify multi-protein signatures associated with the onset of albuminuria (urine albumin-to-creatinine ratio [UACR] ≥30 mg/g), a rapid decline in estimated glomerular filtration rate (eGFR) [annual eGFR decline >3 mL/min/1.73m2 and/or ≥3.3% at two consecutive visits], and hyperfiltration (≥135 mL/min/1.73m2 at two consecutive visits). Elastic net Cox regression with 10-fold cross-validation was applied to the top 100 proteins (ranked by p-value) to identify multi-protein signatures of time to development of DKD outcomes.
Participants in the TODAY study (14±2 years old, 63% female, 7±6 months diabetes duration) experienced high rates of early DKD: 43% developed albuminuria, 48% hyperfiltration, and 16% rapid eGFR decline. Increased levels of seven and three proteins were predictive of shorter time to develop albuminuria and rapid eGFR decline, respectively; 118 proteins predicted time to development of hyperfiltration. Elastic net Cox proportional hazards model identified multi-protein signatures of time to incident early DKD with concordance for models with clinical covariates and selected proteins between 0.81 and 0.96, while the concordance for models with clinical covariates only was between 0.56 and 0.63.
Our research sheds new light on proteomic changes early in the course of youth-onset type 2 diabetes that associate with DKD. Proteomic analyses identified promising risk factors that predict DKD risk in youth with type 2 diabetes and could deepen our understanding of DKD mechanisms and potential interventions.
Albuminuria and Rapid Kidney Function Decline as Selection Criteria for Kidney Clinical Trials in Type 1 Diabetes Mellitus.
Clinical Journal of the AmericanClinicalTrials.gov, NCT02017171.
This study analyzed data from the Preventing Early Renal Loss in Diabetes (PERL) clinical trial, which investigated whether allopurinol slowed kidney function decline in persons with T1D and early-to-moderate DKD. Rates of iohexol GFR (iGFR) and estimated GFR (eGFR) decline during the three-year study were compared by linear mixed effect regression between participants enrolled based on a history of moderately or severely increased albuminuria (N=394) and those enrolled based on a recent history of rapid kidney function decline (≥3 ml/min/1.73 m2/year) in the absence of a history of albuminuria (N=124). The association between baseline albuminuria and iGFR/eGFR decline during the trial was also evaluated.
Rates of eGFR decline during the trial were higher in participants with a history of albuminuria than in those with a history of rapid kidney function decline (-3.56 [95% confidence intervals {CI} -3.17, -3.95] versus -2.35 [95% CI: -1.86, -2.84] ml/min/1.73 m2/year, p=0.001). Results were similar for iGFR decline, although the difference was not significant (p=0.07). Within the history of albuminuria group, the rate of eGFR decline was -5.30 (95% CI -4.52, -6.08) ml/min/1.73m2/year in participants with severely increased albuminuria as compared to -2.97 (95% CI 2.44, -3.50) and -2.32 (95% CI -1.61, -3.03) ml/min/1.73m2/year in those with moderately increased or normal/mildly increased albuminuria at baseline (p<0.001).
Severely increased albuminuria at screening is a powerful criterion for selecting persons with T1D at high risk of kidney function decline. A history of rapid eGFR decline without a history of albuminuria is less effective for this purpose but it can still identify individuals with T1D who will lose kidney function more rapidly than expected from physiological aging.
African American Patients' Perspectives on Determinants of Hemodialysis Adherence and Use of Motivational Interviewing to Improve Hemodialysis Adherence.
Clinical Journal of the AmericanCompared to White patients, African American (AA) patients have a four-fold higher prevalence of kidney failure and higher hemodialysis non-adherence. Adherence behaviors are influenced by psychosocial factors, including personal meaning of a behavior and self-confidence to enact it. We assessed perspectives of AA hemodialysis patients on unique factors impacting dialysis adherence, and use of motivational interviewing, an evidence-based intervention, to improve these factors, dialysis adherence, and outcomes in AAs.
Self-identified AA hemodialysis patients (N=22) watched a brief video describing motivational interviewing and then completed a semi-structured interview or focus group session. Interview questions explored unique barriers and facilitators of hemodialysis adherence in AAs, and perceived utility of motivational interviewing to address these obstacles. Verbatim transcripts and an iterative inductive/deductive approach were used to develop a hierarchical coding system. Three experienced coders independently coded the same two transcripts. Coding was compared and discrepancies were reconciled by a fourth coder or consensus. Transcripts, quotations, and codes were managed using Microsoft Excel 2016 and SPSS version 28.0.
Themes and sub-themes emerged and culminated in a novel conceptual model informed by three theoretical models of behavior change: Theory of Self-Care Management for Vulnerable Populations; Social Cognitive Theory; and Self Determination Theory. This conceptual model will inform the design of a culturally tailored, motivational interviewing-based intervention to improve dialysis adherence in AAs.
Integrating AA hemodialysis patient perspectives is critical for enhancing dialysis care delivery and the design of effective interventions such as motivational interviewing to improve dialysis adherence in AA and promote kidney health equity. AA hemodialysis patients view motivational interviewing as a tool to clarify patient priorities, build trust, and promote patient-provider therapeutic alliance. Cultural tailoring of motivational interviewing to address unique barriers of AAs with kidney failure will improve adherence and health outcomes in these vulnerable patients.
Living Donation and Pregnancy-Related Complications: State of the Evidence and Call To Action for Improved Risk Assessment.
Clinical Journal of the AmericanLiving kidney donation and living liver donation significantly increases organ supply to make lifesaving transplants possible, offering survival be...
Sudden Cardiac Death Reporting in US Dialysis Patients: Comparison of USRDS and National Death Index Data.
Clinical Journal of the AmericanCause-specific mortality data from the United States Renal Data System (USRDS) form the basis for identifying cardiovascular disease (CVD), specifically sudden cardiac death (SCD), as the leading cause of death for patients on dialysis. Death certificate data from the National Death Index (NDI) is the epidemiological standard for assessing causes of death for the United States population. The cause of death has not been compared between the USRDS and the NDI.
Among 39,507 adults starting dialysis in the US, we identified 6436 patients who died between 2003-2009. We classified the cause of death as SCD, non-SCD CVD, cancer, infection, and others; and compared the USRDS to the NDI.
Median age at the time of death was 70 years, 44% were female, and 30% were non-Hispanic Black individuals. The median time from dialysis initiation to death was 1.2 years. Most deaths occurred in-hospital (N=4681, 73%). The overall concordance in cause of death between the two national registries was 42% (κ=0.23, 95% confidence interval 0.22 to 0.24). CVD, including SCD and non-SCD CVD, accounted for 67% of deaths per the USRDS but only 52% per the NDI; this difference was mainly driven by the larger proportion of SCD in the USRDS (42%) versus the NDI (22%). Of the 2962 deaths reported as SCD by the USRDS, only 35% were also classified as SCD by the NDI. Out-of-hospital deaths were more likely to be classified as SCD in the USRDS (60%) versus the NDI (29%), compared to in-hospital deaths (41% in the USRDS; 25% in the NDI).
Significant discordance exists in the causes of death for patients on dialysis reported by the USRDS and the NDI. Our findings underscore the urgent need to integrate NDI data into the USRDS registry and enhance the accuracy of cause-of-death reporting.
Impairment of Cardiovascular Functional Capacity in Mild to Moderate Kidney Dysfunction.
Clinical Journal of the AmericanTraditional diagnostic tools that assess resting cardiac function and structure fail to accurately reflect cardiovascular alterations in patients with chronic kidney disease (CKD). This study sought to determine whether multidimensional exercise response patterns related to cardiovascular functional capacity can detect abnormalities in mild-to-moderate CKD.
In a cross-sectional study, we examined 3,075 participants from the Framingham Heart Study (FHS) and 451 participants from the Massachusetts General Hospital Exercise Study (MGH-ExS) who underwent cardiopulmonary exercise testing (CPET). Participants were stratified by estimated glomerular filtration rate (eGFR): eGFR ≥90; eGFR 60-89; eGFR 30-59. Our primary outcomes of interest were peak oxygen uptake (VO2Peak),VO2 at anaerobic threshold (VO2AT), and the ratio of minute ventilation to carbon dioxide production (VE/VCO2). Multiple linear regression models were fitted to evaluate the associations between eGFR group and each outcome variable adjusted for covariates.
In the FHS cohort, N=1,712 (56%) had an eGFR ≥90 ml/min/1.73m2, N=1,271 (41%) had an eGFR 60-89 ml/min/1.73m2, and N=92 (3%) had an eGFR 30-59 ml/min/1.73m2. In the MGH-ExS cohort, N=247 (55%) had an eGFR ≥90 ml/min/1.73m2, N=154 (34%) had an eGFR 60-89 ml/min/1.73m2, and N=50 (11%) had an eGFR 30-59 ml/min/1.73m2. In FHS, VO2Peak and VO2AT were incrementally impaired with declining kidney function (p<0.001); however this pattern was attenuated following adjustment for age. Percent-predicted VO2Peak at AT was higher in the lower eGFR groups (p<0.001). In MGH-ExS, VO2Peak and VO2AT were incrementally impaired with declining kidney function in unadjusted and adjusted models (p<0.05). VO2Peak was associated with eGFR (p<0.05) in all models even after adjusting for age. On further mechanistic analysis, we directly measured cardiac output (CO) at peak exercise via right heart catheterization and found impaired CO in the lower eGFR groups (p≤0.007).
CPET-derived indices may detect impairment in cardiovascular functional capacity and track cardiac output declines in mild to moderate CKD.
Incidence and Proportion of Primary Focal Segmental Glomerulosclerosis (FSGS) among a Racially and Ethnically Diverse Adult Patient Population between 2010-2021.
Clinical Journal of the AmericanFocal segmental glomerulosclerosis (FSGS) refers to a pattern of glomerular injury but also includes primary FSGS which is considered as an immune mediated glomerulopathy. We sought to determine the incidence of primary FSGS and proportion of FSGS patients with primary FSGS among a large diverse patient population in the United States.
A cross-sectional study (2010-2021) was performed within an integrated health system in patients (age ≥18yrs) with biopsy-proven FSGS. Among biopsies with FSGS as the first diagnosis on pathology report, chart reviews were performed to determine primary FSGS, defined as podocyte foot process effacement ≥80% on electron microscopy. The proportion of patients with primary FSGS and annual incidence rates (per 100,000 patient-years) were calculated. Standardized incidence rates were determined by age, sex, and race and ethnicity based on US population structure of the five-year (2018-2022) American Community Survey estimates.
We identified 3,838 patients with FSGS reported on biopsy. Among 1,502 with FSGS as the principal diagnosis, 637 met criteria for primary FSGS (mean [SD] age 55.5 years [17.9], 56.5% male, 35.6% Hispanic, 28.7% White, 17.9% Asian/Pacific Islander, and 16.0% Black). The mean standardized incidence rate [CI] of primary FSGS was 1.7 [0.9, 2.5] per 100,000 patient-years during the study period. The standardized annual incidence rates ranged from 1.3 - 2.4 per 100,000 patient-years. Incidence rates (per 100,000 patient-years) were highest among Black (3.2), Asian (2.7), and Pacific Islander (2.8) patients.
Primary FSGS accounted for 16.6% of biopsy-proven FSGS. Primary FSGS is a likely a rare disease with incidence highest among Black, Asian, and Pacific Islander people. More precise identification of primary FSGS may facilitate work to improve understanding of this glomerulopathy and improve kidney outcomes.
Prevalence and Outcomes of Chronic Kidney Disease Associated Pruritus: International Results from PDOPPS.
Clinical Journal of the AmericanPruritus is common in hemodialysis (HD) patients. Less is known about the prevalence and outcomes of pruritus among patients receiving peritoneal dialysis (PD). Herein, we describe the prevalence of pruritus and its associations with patient-reported outcomes (PROs) and mortality/transfer to HD.
We analyzed a multicenter, international cohort of PD patients enrolled in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014-2022. Pruritus was assessed at entry into PDOPPS with a single-question Likert Scale capturing the extent to which patients were bothered by itch ranging from 1: Not at all, to 5: Extremely. The KDQOL-36 and the Centre for Epidemiological Studies Depression Scale assessed various PROs. Moderate to extreme pruritus was defined as a Likert scale score ≥3. The associations of pruritus with PROs were assessed using linear/logistic regression where appropriate. Death or HD transfer was assessed using multivariable Cox regression models.
Overall, 5535 patients from seven countries were included; 43% had moderate to extreme pruritus which was highest in Thailand (50%) and lowest in the United States (33%). The adjusted odds ratios (aOR) of moderate to extreme pruritus were higher for diabetes, low albumin, and elevated phosphorus but lower for residual urine volume (aOR= 0.98 per 200 ml increase in 24-hour urine volume, 95% confidence interval [CI]; 0.96-1.00, P=0.05). Patients with extreme pruritus had the lowest mental and physical health component scores and a higher burden of other PROs including restless legs and disturbed sleep. Overall, 899 patients died and 1221 transferred to HD. Patients with moderate to extreme pruritus were at higher adjusted risk for death or HD transfer (adjusted hazard ratio [aHR] 1.12, 95% CI 1.02-1.23, P=0.02) with similar point estimates for each subcomponent of the composite outcome.
Pruritus is highly prevalent in PD and associated with poor health outcomes. Efforts to better identify and manage pruritus should be considered in this population.
Breast and Prostate Cancer Screening by Life Expectancy in Patients with Kidney Failure on Dialysis.
Clinical Journal of the AmericanThe Choosing Wisely campaign suggests an individualized approach to cancer screening among patients receiving dialysis. We aimed to evaluate breast and prostate cancer screening among patients receiving maintenance hemodialysis (HD) by kidney transplant waitlist status and five-year survival probability.
We conducted a retrospective cohort study using a nationally representative population of HD patients. Patients receiving HD each calendar year from 2003-2018, ≥1 year of Medicare as the Primary Payer, and age 50-69 years were included. The cohort was split into prognosis and cancer screening sets. Models of five-year survival were built in the prognosis set using logistic regression. Five-year survival probabilities were generated in the cancer screening set, excluding patients with prior breast or prostate cancer, and screening over the next year was assessed.
160,537 patients contributed 356,165 person-years to the cancer screening set (59% of the person-years were contributed by males, median age was 60 years). Compared to a benchmark rate of 50% (e.g., mammography every other year), 42% of waitlisted female-years were screened by mammography. Overall, 17% of non-waitlisted female-years were screened (20% among those with >50% probability of five-year survival and 8% among those with <10% probability of five-year survival). Compared to a benchmark rate of 20% [e.g., serum prostate-specific antigen (PSA) screening up to five years apart], 24% of waitlisted male-years were screened with serum PSA. Overall 15% of non-waitlisted male-years were screened (13% among those with >50% probability of five-year survival and 1% among those with <10% probability of five-year survival). Patterns were similar after age-standardization.
Patients with higher predicted survival have higher rates of cancer screening, suggesting providers consider life expectancy. However, non-waitlisted patients with high probability of five-year survival were less likely to be screened compared to waitlisted patients. Interventions may be needed to close this screening gap.
Incorporation of Calcimimetics into ESRD Bundle: Changes in Etelcalcetide Utilization and PTH Control Following End of TDAPA Designation.
Clinical Journal of the AmericanCalcimimetics, including intravenous etelcalcetide and oral cinacalcet, are often prescribed to hemodialysis patients to prevent complications of elevated parathyroid hormone (PTH) levels. In January 2021, US dialysis reimbursement policy switched from the transitional drug add-on payment adjustment (TDAPA) to an increased bundled payment, with $10.09 per session added for all hemodialysis patients to cover the expense for calcimimetics, whether or not patients are administered etelcalcetide. We leveraged this natural experiment to investigate the impact of this policy change.
This analysis included 713 US in-center hemodialysis patients enrolled in the United States Dialysis Outcomes and Practice Patterns Study (US-DOPPS) who discontinued etelcalcetide during the TDAPA transition period (December 2020 - April 2021). Within a self-matched longitudinal design, within-patient changes in mean PTH, calcium, and phosphorus were assessed in the six months pre- vs. post- etelcalcetide discontinuation, using linear regression adjusted for potential confounders.
Etelcalcetide use in US-DOPPS decreased 58%, from 12% to 5% from July 2020 to July 2021; 73% of etelcalcetide discontinuers switched to cinacalcet within six months. Comparing the six months pre- vs. post- etelcalcetide discontinuation, mean PTH levels increased by 107 (95% CI: 80, 133) pg/mL, and the prevalence of PTH >600 pg/mL increased by 15% (95% CI: 11%, 19%), from 28% to 43% overall, and increased from 26% to 49% among Black patients. Mean serum calcium and phosphorus levels increased by 0.42 and 0.16 mg/dL, respectively.
Etelcalcetide use decreased substantially after TDAPA ended in January 2021, with most patients switching to cinacalcet. The subsequent increase in PTH levels was swift and sustained, and especially pronounced among Black patients, raising concerns about disparities and potential downstream impact on clinical outcomes. Despite the spirit of the policy change, the flat per-treatment increased payment may have inadvertently created a financial incentive to restrict patient access to a more effective therapy, and potentially stifle drug innovation.
Rituximab Induced Rare Cystic Lesion in Lungs in a Nephrotic Child: A Case Report.
Indian Journal of NephrologyRituximab has been extensively used for managing B-cell lymphomas due to its anti-CD20 monoclonal antibody activity. Over the last decade, its appl...