Latest news with #kidneyfailure
Asharq Al-Awsat
a day ago
- Health
- Asharq Al-Awsat
KSrelief Launches Vital Kidney Dialysis Project for Sudanese Patients in Egypt
The King Salman Humanitarian Aid and Relief Centre (KSrelief) launched a crucial project in Cairo to support Sudanese patients suffering from kidney failure in Egypt. This initiative is a collaborative effort with the World Health Organization and the Egyptian Ministry of Health, SPA reported. The project will extend its reach across several Egyptian cities, including Cairo, Giza, Alexandria, Luxor, and Aswan. It focuses on three key objectives: ensuring life-saving healthcare services, mapping service providers in areas with high Sudanese populations, and guaranteeing sustainable access to treatment. Egyptian Minister of Health Dr. Khaled Abdel Ghaffar emphasized that the project aims to provide 90,000 dialysis sessions annually, along with comprehensive pharmaceutical and therapeutic services in Egyptian hospitals. Director of KSrelief's Health and Environmental Aid Department Dr. Abdullah Al-Moallem underscored that this launch exemplifies Saudi Arabia's ongoing humanitarian and relief efforts worldwide. He emphasized the solidarity and cooperation among Saudi Arabia, Egypt, and Sudan, and noted that KSrelief has provided over $165 million in aid to the Sudanese people since the onset of the humanitarian crisis in Sudan.
Associated Press
3 days ago
- Business
- Associated Press
Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy
CAMBRIDGE, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, PROMINENT. The Phase 3 study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary membranous nephropathy (PMN). PROMINENT is designed to enroll approximately 180 adults with PMN and expected to readout in 2029. PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure. Felzartamab is an anti-CD38 antibody that has been shown in clinical studies to selectively deplete CD38+ cells, including plasma cells, the source of autoantibodies that mistakenly attack the body's own tissues in a range of immune-mediated diseases. Importantly for felzartamab, it is estimated that up to 80% of PMN patients have autoantibodies against PLA2R (aPLA2R) generated by CD38-expressing plasma cells. Currently, there are no approved treatments for PMN and the standard of care includes treatments ranging from immunosuppressants to chemotherapy.2 'We are encouraged by the opportunity to advance a Phase 3 study for primary membranous nephropathy, a condition that carries a significant risk of kidney failure,' said Travis Murdoch, Head of the Biogen West Coast Hub. 'This is the third Phase 3 trial of felzartamab launched by Biogen this year, underscoring our ongoing commitment to developing potential novel treatment options for patients living with kidney disease.' PROMINENT is a 104-week, randomized, open-label, global multicenter Phase 3 trial ( NCT06962800 ) to evaluate the efficacy and safety of felzartamab compared with tacrolimus in moderate- to -high-risk participants with PMN, inclusive of newly diagnosed and relapsed patients, in achieving complete remission of proteinuria. Participants will be randomized to receive either felzartamab or tacrolimus with the primary endpoint being the percentage of participants who achieve complete remissions (CR) at week 104. The study will evaluate both anti-PLA2R (aPLA2R) autoantibody positive and negative patients, stratifying participants based on PLA2R levels. Key secondary endpoints include the impact of felzartamab on serum anti-phospholipase A2 receptor (PLA2R) antibodies and patient-reported outcomes. 'Primary membranous nephropathy remains an unaddressed area of nephrology, for which there are no approved treatments. Felzartamab's mechanism of action designed to deplete the cells that produce the pathogenic antibodies is exciting news for patients that are waiting for potential meaningful new treatment options,' said Mohamed El-Shahawy, M.D., MPH, MHA, Director of the Academic Research Institute in Los Angeles, Clinical Professor of Medicine at Keck-University of Southern California School of Medicine, and a principal investigator for the PROMINENT Phase 3 trial. 'I'm grateful that Biogen is advancing research in this rare kidney disease and am eager to see the continued progress in the study's enrollment.' Felzartamab was previously investigated in two Phase 2 studies, M-PLACE (n=31) and NewPLACE (n=24), which enrolled patients with aPLA2R-positive PMN. In the final analysis of M-PLACE, reductions in aPLA2R titers were observed in most patients as early as one week (median reduction of 45%), with responses (>50% reduction) in most patients at six months at end-of-treatment. In addition, improvements in proteinuria and serum albumin levels were observed with administration of felzartamab. Across both studies, the majority of treatment emergent adverse events (TEAEs) reported were mild to moderate and consistent with the known mechanism of action of felzartamab in the PMN population. The most common TEAE was infusion-related reactions on the first infusion that were mostly mild to moderate in intensity. In addition to beginning a Phase 3 study of felzartamab in PMN, Biogen also initiated two other Phase 3 studies of felzartamab this year, TRANSCEND ( NCT06685757 ) for late antibody-mediated rejection in adult kidney transplant recipients and PREVAIL ( NCT06935357 ) in IgA nephropathy. About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established. About Primary Membranous Nephropathy (PMN) PMN is a severe antibody-mediated disease of the kidney that is a leading cause of nephrotic syndrome and carries a significant risk of kidney failure, with an estimated prevalence of ~36k patients in the United States.1 Patients with nephrotic syndrome often present with very severe swelling and fatigue related to high-grade proteinuria, and they are also at an increased risk of infection. There are no approved treatments for PMN and the current standard of care includes treatments ranging from immunosuppressants to chemotherapy.2 Even with these strategies, approximately one third of patients do not achieve remission.2 About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This press release contains forward-looking statements, relating to: our strategy and plans; potential of, and expectations for the design, timing and results of the PROMINENT study, the ability of felzartamab to treat AMR, PMN or IgAN, our commercial business and pipeline programs; capital allocation and investment strategy; clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, our future financial and operating results. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. References:
Medscape
7 days ago
- Health
- Medscape
COVID-19 Hospitalisation Tied to Higher Kidney Failure Risk
TOPLINE: Patients with COVID-19 who required hospitalisation had a more than sevenfold higher risk for kidney failure than individuals without the condition, with this elevated risk persisting beyond 180 days. No elevated risk was observed among non-hospitalised patients. METHODOLOGY: Researchers conducted a population-based cohort study using linked primary and secondary care data from England through the OpenSAFELY platform to assess the long-term risk for kidney failure following COVID-19. They included 3,544,310 patients (median age, 44 years; 53.2% women) with COVID-19 and 10,031,535 matched individuals without COVID-19; 6.9% of patients with COVID-19 were hospitalised. Participants without preexisting kidney failure (initiation of dialysis or kidney transplant or estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73 m 2 ) and with at least 3 months of prior follow-up were included. ) and with at least 3 months of prior follow-up were included. The median follow-up duration was 446 days for patients with COVID-19 and 410 days for matched individuals. Follow-up started from 28 days after the diagnosis of COVID-19. The primary outcome was the time to kidney failure; secondary outcomes were a 50% reduction in the eGFR and all-cause death. TAKEAWAY: Patients hospitalised with COVID-19 had a more than sevenfold higher risk for kidney failure than matched control individuals (adjusted hazard ratio [aHR], 7.74; 95% CI, 7.00-8.56), with the risk persisting beyond 180 days of follow-up; the risks for kidney failure were particularly pronounced among those admitted to the ICU or with acute kidney injury during hospitalisation. COVID-19 requiring hospitalisation was also significantly associated with increased risks for a 50% reduction in the eGFR (aHR, 3.49; 95% CI, 3.25-3.75) and death (aHR, 4.93; 95% CI, 4.83-5.04). No increased risk for kidney failure was found among non-hospitalised patients (aHR, 0.85; 95% CI, 0.79-0.90). Black ethnic groups faced significantly higher risks for kidney failure than White or South Asian ethnic groups. IN PRACTICE: "Our results suggest that interventions to minimise the risk of severe COVID-19 should continue to be optimised among vulnerable groups, and that kidney function should be proactively monitored after discharge," the authors wrote. SOURCE: This study was led by Viyaasan Mahalingasivam, London School of Hygiene & Tropical Medicine, London, England. It was published online on June 18, 2025, in The Lancet Regional Health - Europe. LIMITATIONS: The removal of higher-risk individuals from the non-hospitalised group may have led to an underestimation of the risk for kidney outcomes in this group compared with non-infected comparators. Detecting a 50% reduction in the eGFR relied on regular blood tests, which were more common in patients with chronic health conditions and may have inflated observed risks due to more frequent monitoring. Additionally, some important covariates, such as occupation and type of vaccination, were not included in the analysis. DISCLOSURES: This study was funded through a Career Development Award from the National Institute for Health and Care Research. Some authors reported receiving research grants or funding, travel grants, awards, reimbursements, fellowships, honoraria, and consulting fees and having other ties with several pharmaceutical companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Wall Street Journal
25-06-2025
- Health
- Wall Street Journal
Why a Medicaid Penalty Would Prove Costly
The Senate's reconciliation bill, which would reduce the federal Medicaid match for states that cover certain healthcare services for immigrants living in the U.S. unlawfully, may sound like a way to cut federal spending. In reality, it would increase healthcare costs, strain emergency rooms and make healthcare worse for all ('Blue States Reverse Course on Insuring Undocumented,' U.S. News, June 20). Consider that outpatient dialysis costs about $90,000 a year, while emergency inpatient dialysis can exceed $300,000 annually. That extra cost falls on hospitals, state budgets and, ultimately, the taxpayer. That's why 20 states, both Democratic- and Republican-led, have chosen to provide outpatient dialysis through Medicaid. It isn't about immigration policy or a gesture of generosity; it is fiscally responsible. Patients with kidney failure need dialysis three times a week to survive. Immigrants here unlawfully typically can't access private insurance or Medicaid. That doesn't mean they go without care; it means they show up in emergency rooms when their condition is life-threatening. Under federal law, hospitals must treat anyone in an emergency, regardless of immigration or insurance status.
Daily Mail
18-06-2025
- Health
- Daily Mail
Girl, 2, on life support after unseen danger infected her during family trip to pretty lake
A two-year-old girl is on life support and battling kidney failure after a family trip to a picturesque Oklahoma lake ended up as a nightmare vacation. Elizabeth Faircloth, 2, was left fighting for her life after she contracted three strains of E. coli which her parent believe to have come from swimming in Keystone Lake earlier this month. Keystone Lake, a reservoir in Oklahoma, is a popular destination for swimming, boating, water sports, and fishing. The child is now medically paralyzed, on dialysis, and suffering from multiple organ damage as she fights for her life. Elizabeth's family shared heartbreaking photos of their daughter hooked up to breathing tubes and medical monitors in the hospital. She is battling Hemolytic-Uremic Syndrome (HUS), a rare life-threatening complication from E. coli that can cause severe kidney failure, liver damage, and brain injury, according to a GoFundMe campaign launched by relatives, 'Hi, my name is Grayson and this is my sister Elizabeth,' her sister wrote in the GoFundMe. 'She is currently fighting kidney failure.' 'At the moment, doctors are trying to get a toxin out of her body, which is constantly attacking her liver, kidneys, and other organs.' Her sister lovingly described Elizabeth as a 'great, crazy kid' who 'loves meeting new people.' 'She is fighting every day to stay with us,' she wrote. 'She is a great, crazy kid and loves meeting new people, so please help out. A little can go a big way for us. The fundraiser has reached $8,248 raised of its $10K goal so far. A relative shared an update regarding the child's condition on Facebook this week, with positive news saying she is 'awake and off the tube.' 'She is awake and off the tube but there was a very scary breathing issue after they took her off the tube yesterday,' Kelly Faircloth shared on Facebook. 'They got that squared away and she is in and out with her sedating meds, she continued. She explained that Elizabeth is now fighting an infection in the lungs. 'Now she has an infection in the lungs which they have to use antibiotics to stop,' she wrote. 'But antibiotics excellerate [sic] the three Ecoli strands HUS, so it's a monitoring game of chasing our ass.' 'Still a long and unknown road but our baby is still fighting!' 'It's a nightmare, and it happened so fast,' her mother, Suzanne Faircloth, told KOTV. 'Within like a week, we're here.' 'It blows our minds, because we've never even heard of anything like this ever happening,' Suzanne said. 'We've heard of E. coli - but usually in hamburgers.' 'They are working night and day - the staff is amazing - just to keep her stable,' Faircloth said. 'It kind of feels like you're drowning and you get brief moments of air just enough to keep you alive, but there's no end in sight.'
