Latest news with #albuminuria
Medscape
20-06-2025
- Health
- Medscape
Smartphone-Based Home Albuminuria Testing Boosts Screening
TOPLINE: Screening for albuminuria, a key marker of cardiorenal risk, remains inadequate among patients with diabetes or hypertension. A smartphone-enabled home testing solution, evaluated in 4000 adults, effectively increased screening rates and enabled early diagnosis of kidney disease. METHODOLOGY: Regular albuminuria testing is recommended in high-risk patients with diabetes or hypertension to enable early detection and timely intervention for kidney and cardiovascular complications; however, screening levels remains suboptimal. Researchers randomly selected 4000 adults (mean age, 61 years; 49% women; 93% White) from a large Central Pennsylvania healthcare system who had not undergone albumin-creatinine ratio testing in the previous 12 months; half the patients in the cohort had hypertension without diabetes, and the remaining half had diabetes. Patients were provided with Minuteful Kidney, an FDA-cleared, smartphone-enabled home albuminuria screening kit. Results were delivered to participants via a smartphone application and to healthcare providers through electronic health records. The intervention group was propensity score-matched with a control group receiving usual care. TAKEAWAY: Completion rates for any albumin-creatinine ratio testing were significantly higher in the intervention group than in the control group (53.1% vs 21.2%; P < .001). The impact of the intervention on albumin-creatinine ratio testing completion was more pronounced among patients with hypertension without diabetes (completion rates, 53.4% in the intervention group vs 12.5% in the control group) than among those with diabetes (completion rates, 52.7% vs 30.0%). Over 270 days of follow-up, patients tested with Minuteful Kidney had higher rates of new diagnoses of proteinuria or kidney disease (4.0% vs 2.2%; P < .001). Patients with an abnormal albumin-creatinine ratio on the home-based test demonstrated greater engagement with primary care and nephrology services and were more likely to receive prescriptions for renin-angiotensin-aldosterone system inhibitors than were those with normal results. IN PRACTICE: "A smartphone-enabled home albuminuria test is effective in increasing albuminuria screening and diagnosis of kidney disease among high-risk individuals," the authors concluded. SOURCE: The study was led by Waleed Zafar in Danville, Pennsylvania. It was presented on June 20, 2025, at the 85th Scientific Sessions – American Diabetes Association held at the McCormick Place Convention Center, Chicago. LIMITATIONS: The abstract did not discuss any limitations. DISCLOSURES: Two authors disclosed receiving research support from various pharmaceutical companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
13-06-2025
- Health
- Medscape
Is Albuminuria Screening the Answer to Tackling Unseen CKD?
VIENNA — Only 7%-20% of people with chronic kidney disease (CKD) in the US are aware of their condition; meanwhile, the disease is projected to become the fifth leading cause of death globally by 2050. But what is the best way to change these statistics? Facing off on opposite sides of a debate at 62nd European Renal Association (ERA) Congress 2025 on whether or not population screening of albuminuria is the answer were Ronald T. Gansevoort, MD, PhD, University Medical Center Groningen, Groningen, the Netherlands, and Joseph A. Vassalotti, MD, Icahn School of Medicine at Mount Sinai, New York City. While the two speakers agreed on the importance of early detection of CKD and the limitations of current practice, they diverged on the best path forward. The Case for Population Screening 'Albuminuria is by far the strongest predictor for kidney function decline,' said Gansevoort, who argued for broad screening. 'It can occur in an early stage of kidney disease, when kidney function is still normal,' he said, adding that it is often accompanied by as yet unknown — or poorly controlled — diabetes, hypertension, hyperlipidemia, and even cardiovascular disease. He illustrated the gravity of the situation with a stark comparison: Patients on dialysis have 5-year survival rates similar to those of patients with colorectal cancer. Worse, survival is improving slightly in patients with cancer, whereas survival in patients on dialysis has not improved at all over the past few decades, he noted. Gansevoort stressed the importance of identifying individuals at risk before a decline in the glomerular filtration rate begins, pointing to the increased availability of effective interventions, including SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists. To demonstrate the feasibility of screening, he presented results from THOMAS, a Dutch prospective, randomized, open-label implementation study comparing two home-based screening methods. Using a urine collection kit returned by post, the study achieved a 59% participation rate and identified confirmed high albuminuria in 3.3% of participants. Among those with albuminuria, 90% had newly diagnosed or poorly controlled comorbidities such as hypertension or high cholesterol. Yet only 54% of referred patients actually visited their general practitioner. There's definitely room for improvement there, Gansevoort acknowledged. Nonetheless, he argued that population screening was cost-effective when done at home. The researchers from THOMAS calculated a cost of €9225 per quality-adjusted life-year (QALY), far below typical European thresholds. 'It's already cost-effective,' he noted, adding that integrating albuminuria testing into existing national screening programs, such as those for colorectal cancer or cardiovascular disease, could further boost cost-effectiveness and increase participation. He described the newly launched Check@Home study — a collaborative effort by the Dutch CardioVascular Alliance, the Dutch Heart Foundation, the Kidney Foundation, and the Diabetes Research Foundation — that combines screening for both CKD and cardiovascular disease. He also highlighted the recently begun CASCADE CKD study, which uses a single at-home kit incorporating both urine and fecal collection to screen simultaneously for CKD and colorectal cancer. 'How easy would it be in the same package to have a second tube to collect some urine and to detect patients with chronic kidney disease?' he asked. By sharing logistical infrastructure, 'It will definitely improve cost-effectiveness even further,' he noted. The Case Against Vassalotti, speaking against general population screening, began with a concession: 'I'm not against population screening for albuminuria,' he said. 'Rather, I think case finding among risk groups is more feasible, sustainable, and impactful.' He emphasized the importance of context, asking the audience to consider 'the public, the patients, the primary care clinicians, and the policymakers. In the US, even among those diagnosed, only half receive urine albumin testing.' 'We're not even doing a good job managing people with CKD,' he said. 'We should implement better case finding or opportunistic screening to start with.' Cost was another sticking point. Vassalotti cited a US study that used Markov models to assess population-wide CKD screening and put the cost at $86,300 per QALY for adults aged 55 years or older, a figure above commonly accepted thresholds. 'Implementation was assumed to be 100%,' he said, 'which in the US is quite a stretch.' Vassalotti praised Gansevoort's THOMAS study but questioned its scalability. 'How can you screen the general population if only 59% participate?' he asked. He added that participation in the US might be even lower, given the lack of public awareness and fragmented health infrastructure. He concluded by advocating for primary care engagement and better CKD education. 'Perceived risk will help us manage the risk condition,' he said. 'And that will result in more awareness, increased detection, and improved management.' Agreement on Need for Action In a rebuttal, Gansevoort reiterated that his model was already more cost-effective than those cited by Vassalotti. 'We do it in the home setting, making it far less costly,' he said. He also called for a more pragmatic view on participation. 'We are not going to save everybody,' he said. 'But should we not save many people because some do not like to be screened?' Vassalotti, in turn, emphasized the need to work on education, for the public, patients, and clinicians alike, before expanding screening. 'How can you screen the public for kidney disease,' he asked, 'when they don't even know what it is?' One key issue emerging from the closing discussion was how often screening should occur. 'It has not been decided yet,' Gansevoort admitted. 'We're looking into Markov models, perhaps a fixed interval or a patient-specific interval.' Vassalotti argued for simplicity: 'Annual screening is something that we can disseminate easily,' he said. 'Less frequent screening is more difficult to socialize.' Despite their differences, both speakers emphasized the need for action. 'We now have effective, sufficiently safe, and affordable treatments,' Gansevoort said. 'The present opportunistic screening approach has proven not to work.' For Vassalotti, the path forward must be grounded in context. 'Every country should develop its own approach,' he said. 'Whether it be population screening or case finding.' No funding was declared. Gansevoort declared having relationships with AbbVie, AstraZeneca, Baxter, Bayer, Dutch Kidney Foundation, Galapagos, Happitech, Health~Holland, Ipsen, Mironid, Roche, Sanofi Genzyme, Sandoz, and Otsuka Pharmaceuticals. Vassalotti declared having relationships with Novo Nordisk and Sanofi.
Medscape
05-06-2025
- Health
- Medscape
Combination Therapy Offers CONFIDENCE to CKD+T2D Patients
VIENNA — Combining the SGLT2 inhibitor empagliflozin with finerenone, a nonsteroidal mineralocorticoid receptor antagonist (MRA), markedly and durably reduced albuminuria in patients with both chronic kidney disease (CKD) and type 2 diabetes (T2D), the CONFIDENCE trial showed in findings that offer hope of a long-term improvement in outcomes. In the trial, 70% of patients on both therapies achieved the American Diabetes Association recommended urinary albumin-to-creatinine ratio (UACR) reduction target of > 30%. 'Since UACR is a key mediator of kidney and cardiovascular outcomes, these results are highly relevant for clinical decision-making,' said lead researcher Rajiv Agarwal, MD, MS, professor emeritus of medicine, Indiana University School of Medicine, Indianapolis. The results were presented here at the 62nd European Renal Association (ERA) Congress 2025 on June 5 and sparked enthusiastic applause from the audience. The findings were simultaneously published in The New England Journal of Medicine. Agarwal, who shared the podium with three of his co-investigators to present the study, added that this was in keeping with 'other chronic conditions like heart failure or hypertension,' in that 'we're moving away from the traditional stepwise approach toward upfront combination therapy.' Session co-chair Mustafa Arici, MD, professor of medicine (nephrology), Hacettepe University, Ankara, Turkey, described the results as 'remarkable.' He told Medscape Medical News , 'For protecting the kidneys of type 2 diabetes patients, it looks like we now have the data to start an SGLT2 inhibitor plus an MRA in combination from the first day, because the data is very solid.' Arici noted, however, that the study did not include clinical endpoints and 'people usually would like to hear solid outcomes. We would like to see whether the number of dialyses decreased or the mortality decreased.' But — as the presenters themselves pointed out — the numbers required to show a clinical benefit are too large to feasibly conduct a trial, he said. 'Obviously there is a surrogate outcome here, which is the UACR,' said Arici. "And at the moment, we have data from 800 people with a good amount of follow up and with no safety signal, which is important." Implementing and Combining Additional Drugs Co-investigator of the CONFIDENCE study, Peter Rossing, MD, PhD, clinical professor, Steno Diabetes Center, Copenhagen, Denmark, noted that, in terms of treatment, the standard of care in patients with CKD and T2D is based on four pillars, with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) joined in recent years by SGLT2 inhibitors, MRAs, and GLP-1 receptor agonists. 'However, we do not know really how to implement these additional drugs and how to combine them,' Rossing said. Clues have come from combination trials in hypertension and heart failure with reduced ejection fraction, which led to the evolution of guideline recommendations and the mantra that, when it comes to using multiple drugs, it is better to give 'some of all, instead of all of some.' A recent analysis also suggested that steroidal MRAs and SGLT2 inhibitors may have additive effects in reducing UACR, far more than either drug alone, although only 32 patients in the study had both CKD and T2D. In the current trial, patients were enrolled if they had: a UACR of ≥ 100 – < 5000 mg/g; an estimated glomerular filtration rate (eGFR) of 30-90 mL/min/1.73 m2; T2D with an A1c < 11%; and were receiving clinically maximally tolerated doses of ACE inhibitors/ARBs for > 1 month. The participants were randomly assigned to one of three groups: simultaneous finerenone plus empagliflozin; finerenone plus placebo; or empagliflozin plus placebo. Patients were treated for 180 days, with clinical visits on days 14, 30, and 90, and then went through a washout period through to day 210. Choosing a composite kidney endpoint for the primary efficacy analysis would have required 41,000 patients to be enrolled into the trial, explained co-investigator Hiddo J.L. Heerspink, PhD, Department of Clinical Pharmacology, University Medical Center, Groningen, Netherlands. Instead, the researchers opted for the more feasible primary endpoint of relative change in UACR from baseline to day 180, as previous studies have shown that short-term UACR changes are associated with kidney protection in the long term. In all, 818 patients were randomly assigned from 143 sites in 14 countries, of whom 269 ended up receiving the combination therapy, 264 had finerenone monotherapy, and 267 were treated with empagliflozin alone. The mean age of the patients was 67 years, and 75% were male. Forty-six percent were Asian and 44% were White. Turning to the efficacy analysis, Agarwal asked the audience to vote on the percentage reduction in UACR that they expected the combination therapy would achieve. The most common answer, chosen by 37.7% of voters, was 30%-40%. Agarwal then showed that, in fact, combining finerenone with empagliflozin achieved a 52% reduction in UACR over baseline, 32% greater than that seen with empagliflozin alone, and 29% greater than that seen with finerenone monotherapy. 'It's great to see some positive trial results,' he added, in response to the audience's acclamation. In addition, only 52% of patients treated with either drug alone reached a > 30% reduction in UACR at day 180 compared to the 70% of patients treated with the combination. In addition, a total of 64% of patients treated with the combination achieved a > 40% reduction in UACR, and 55% reached a > 50% reduction. In both cases, the proportions of patients reaching the target with monotherapy were approximately 20% lower. The benefit in terms of serum potassium levels was also notable, as there was a 17.7% reduction in the incidence of treatment-emergent hyperkalemia, defined as serum levels > 5.5 mmol/L, with combination therapy vs finerenone monotherapy. Agarwal also noted that there was a low incidence of hypotension with combination therapy, with just three cases (1.1%), and a low incidence of acute kidney injury, at five cases (1.9%). There was an initial decline in eGFR, which was described as 'predictable' and largely reversible after drug withdrawal. Crucially, the researchers also showed that during the washout period, UACR levels returned to almost those seen at baseline. This pattern was also observed with the marked improvements in both serum potassium and blood pressure levels that were seen with finerenone plus empagliflozin, which were again greater than those achieved with either monotherapy. After the data were presented, study co-investigator Johannes F.E. Mann, MD, head, KfH Kidney Center, Munich, Germany, sought to explain the implications of the findings by pointing to a recent mediation analysis of pooled data from two phase 3, double-blind trials of finerenone. This revealed that reductions in UACR over the first 4 months of treatment explained 84% of the later reductions in kidney progression and 37% of the reductions in cardiovascular outcomes, suggesting that the findings from CONFIDENCE may well translate into later improvements in clinical endpoints. Muthiah Vaduganathan, MD, MPH, from the Department of Cardiovascular Medicine at Brigham and Women's Hospital, Boston, welcomed the findings. Commenting on X (formerly Twitter), he said that the simultaneous initiation of the combination therapy 'safely and rapidly delivers' in patients with both CKD and T2D. 'A new age of combination therapies has arrived.' The study was funded by Bayer. Agarwal declares relationships with Akebia Therapeutics, Alnylam, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim, Intercept, Novartis, UpToDate, Wolters Kluwer, Chinook, and Vertex. Rossing declares relationships with AstraZeneca, Bayer, Novo Nordisk, Abbott, Astellas, Boehringer Ingelheim, Eli Lilly, Gilead, Sanofi, Daiichi Sankyo, and Lexicon Pharma. Heerspink declares relationships with Alexion, AstraZeneca, Bayer, Boehringer Ingelheim, BioCity, Dimerix, Eli Lilly, Janssen, Novartis, Novo Nordisk, Roche, and Travere Therapeutics. Mann declares relationships with Novo Nordisk, the European Union, Bayer, AstraZeneca, Bayer, Novartis, UpToDate, Cytel, IQVIA, Parexel, WCG, and Sanofi.
