Vifor Pharma to revise DIAMOND study, readout expected in H2 2021
Vifor Pharma Group today announced that the phase-IIIb DIAMOND study has been amended with new and clinically relevant endpoints, including a new primary endpoint of efficacy in potassium management in high-risk heart failure patients treated with guideline-recommended doses of renin-angiotensin aldosterone system inhibitor (RAASi). This decision has been made on the recommendation from the independent study Executive Committee and following the significant impact of COVID-19 on recruitment.
Patients with heart failure and chronic kidney disease are among those at the highest risk of severe outcomes of COVID-19 infection. During the pandemic, treatment practices have been adapted to reduce risks of exposure to COVID-19 during hospital visits, disrupting clinical care and impacting the conduct of randomized clinical trials such as the DIAMOND study. This has led to fewer patients enrolled in the trial than anticipated and to a slower incidence of cardio-vascular events.
More than 1,000 patients with heart failure and with hyperkalemia or history of hyperkalemia have already been enrolled in DIAMOND. Following the change of endpoints, study read-out and remaining data collection is expected to be completed in 2021.
Prof. Javed Butler, Principal Investigator for the DIAMOND study, said: “Guidelines give strong recommendation to use RAASi to reduce mortality and morbidity in heart failure patients, but unfortunately patients are often treated with low doses, or not treated at all, because RAASi increase potassium levels, which can cause hyperkalemia. The new primary endpoint allows us to investigate the role of Veltassa® in controlling serum potassium and potentially preventing hyperkalemia in heart failure patients treated with RAASi. This will maximize the scientific utility of the data collected in DIAMOND.”
Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group, commented: “We believe that this decision is a responsible approach towards the heart failure patients participating in the trial and towards the need of the medical community to learn from the outcomes of the DIAMOND study. A significant amount of evidence on the use of Veltassa® in combination with RAASi medication has been recorded in DIAMOND. We expect these data to support an effective management of hyperkalemia in patients on RAASi therapy with Veltassa® and look forward to sharing this data during spring 2022 at a major conference.”
Vifor Pharma continues to support several data generation programs with the ongoing phase-IV PLATINUM study and the CARE-HK global study platform to drive evidence-based care using Veltassa® in chronic kidney disease and heart failure patients.
Vifor Pharma will host a conference call today, 24 June 2021 at 10:30 am (CET).
Access to conference call → link
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.
This global, multicenter, double-blind, placebo controlled DIAMOND study was designed to evaluate the potential role of Veltassa® in enabling patients with, or at high risk of, hyperkalemia to remain on RAASi therapy. The previous primary endpoint of the study was the time to first occurrence of cardiovascular death or cardiovascular hospitalization. On recommendation of the independent study Executive Committee and due to COVID-19 impact on recruitment, the primary endpoint has been changed to investigate the role of Veltassa® in controlling serum potassium and potentially prevent hyperkalemia in heart failure patients treated with RAASi. More than 1,000 patients with hyperkalemia or history of hyperkalemia, who are therefore not able to use guideline-recommended doses of RAASi, were enrolled in the study.
Hyperkalemia is a serious condition characterized by elevated levels of potassium in the blood. Patients with chronic kidney disease and heart failure, especially those treated with RAASi, are at particular risk of developing the condition. Studies have shown Veltassa® enables patients to remain on RAASi therapy by effectively managing their chronic hyperkalemia.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Global Head Corporate Communications
+41 79 957 96 73
Head of Investor Relations
+41 58 851 66 90
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Conviva and the Trade Desk Partner to Improve Contextual Advertising for Premium Streaming Publishers29.7.2021 19:04:00 CEST | Press release
Conviva, the intelligence cloud for streaming media, and global advertising technology leader The Trade Desk, have entered a first-of-its-kind partnership to provide the streaming advertising industry the contextual content signals needed in the bidstream to improve their connected TV campaigns based on signals and effectiveness. Together, the two companies will help premium publishers supply programmatic buyers with the network, genre, rating, length and other detailed data sorely lacking in the streaming industry while still maintaining data control. Details of the partnership, product offering, participating publishers and how premium publishers can participate and benefit, will be available via a webinar in August. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005953/en/ The Trade Desk + Conviva (Graphic: Business Wire) According to Conviva’s State of Streaming Advertising report, released in June 2021, only 39% o
New Harris Poll: Cybersecurity Fears May Stall COVID-19 Digital Vaccine Card Adoption in the United Kingdom, Identity Theft and Fake Cards Top List of Concerns29.7.2021 17:02:00 CEST | Press release
Anomali, the leader in intelligence-driven cybersecurity solutions, today announced availability of its latest survey conducted by The Harris Poll. The study, which gathered responses from more than 1,000 adults aged 18 and over in the United Kingdom, reveals that more than three-quarters of British adults have cybersecurity fears around the use of COVID-19 digital vaccination cards. Additional findings showed which entities respondents believe are responsible for protecting them against cyberattacks and who they believe the most likely culprits will be. A majority of respondents predict that a disruptive cyberattack will follow digital vaccine card adoption, findings also reveal confidence levels when it comes to how prepared the nation is to mount a defense. Among key findings: 76% have cybersecurity concerns related to COVID-19 digital vaccination cards. Identity theft topped the list at 51%, with fake vaccine cards that could be used to hack smartphones (44%) and data breaches (45%
QuadraGen Announces the Launch of Its Next Generation Commercial Loan Processing SaaS Platform and Edward Ho Joins As Chairman29.7.2021 16:00:00 CEST | Press release
QuadraGen announces the launch of its next generation commercial loan servicing SaaS platform to help financial institutions transform their complex loan processing capabilities. The QuadraGen Platform supports various areas of loan operations, enabling more efficient and effective processing of loan information, risk management, and decision-making. The QuadraGen SaaS platform consists of a suite of independently deployable microservices that augment existing technology, filling in gaps where processes and functions are not well executed, or replacing legacy capabilities with its next generation software. QuadraGen’s key differentiator is its team of experts, who have decades of commercial lending experience understanding and solving complex loan operation issues. Financial institutions are challenged by the size, complexity, number of participants, and speed of the loan markets. Many institutions use in-house or legacy systems that are inadequate for today’s ever-growing needs. Quadr
Comcast Announces Peacock Coming to Sky29.7.2021 15:30:00 CEST | Press release
Comcast today announced NBCUniversal and Sky will make Peacock available at no additional cost to nearly 20 million Sky customers in Europe. Beginning later this year, Peacock will make its international debut across Sky platforms, including Sky Q, NOW, and Sky Ticket, currently serving customers throughout the UK, Ireland, Germany, Italy, Austria, and Switzerland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005660/en/ “Comcast’s Xfinity has been integral to the success of our go-to-market strategy with Peacock in the U.S., and we see a similar opportunity to expand internationally with Sky,” said Jeff Shell, Chief Executive Officer, NBCUniversal. “We are excited to bring Peacock to millions of Sky customers and add incredible value to their platforms with a premium catalog of the best entertainment from across NBCUniversal that is included with their subscription. By leveraging Comcast’s Xfinity platforms in the U.
BOW Group Acquires Musart, Adding Innovative Art Marketplace to Its Offering29.7.2021 15:15:00 CEST | Press release
BOW Group today announced that it has successfully completed the acquisition of Musart.com, a fast-growing online destination to buy original artworks and licensed products. This transaction will allow BOW Group to seize new opportunities in the booming digital art market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005637/en/ (Photo: Musart) “BOW Group and Musart share the same passion for good yet accessible design that brings emotions to consumers at every moment of the day,” said Boris Brault, BOW Group Founder and CEO. “Together, with Musart’s unique product curation and established relationships with leading institutions, we can conquer the thriving online art market thanks to our global ecommerce, logistics and development capabilities. With Musart in our portfolio, we are expanding our offering and enhancing the growth potential of our business beyond IoT and lifestyle objects. Today, the art world is fundam
IWBI Collaborates with Leading Organizations to Launch WELL Enterprise Provider Designation29.7.2021 15:00:00 CEST | Press release
The International WELL Building Institute (IWBI) today launched the WELL Enterprise Provider (WELL EP) designation for organizations that demonstrate expertise for delivering a comprehensive suite of WELL solutions at a portfolio or enterprise scale. WELL EPs guide their clients to identify and implement WELL strategies, helping companies meet their larger business objectives in areas such as environmental, social and governance (ESG) reporting, human and social capital management, and workplace strategy and policy. Through this new program, IWBI and WELL EPs work together to more efficiently deliver the many benefits of WELL solutions across real estate portfolios and entire organizations. Companies granted the WELL EP designation offer their demonstrated expertise in WELL along with tailored resources to support the growing demand for enhanced health and well-being for employees, customers and communities. “In the wake of the COVID -19 pandemic, the exponential growth of WELL adoptio
MapleStory M Third Anniversary Culminates in Massive Update With New Angelic Buster Character and In-Game Celebration Events29.7.2021 15:00:00 CEST | Press release
MapleStory M, the free-to-play mobile MMORPG for iOS and Android, is continuing its third anniversary celebration with the introduction of Angelic Buster and a host of events for players to enjoy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005175/en/ MapleStory M Third Anniversary Culminates in Massive Update With New Angelic Buster Character and In-Game Celebration Events (Photo: Business Wire) Born as a disgraced Nova without a tail or magic, Angelic Buster inherited the powers of Eskalade, an ancient dragon residing inside an ancient relic of Pantheon. Equipped with a dragon shaped arm cannon, known as Soul Shooter, Angelic Buster is able to blast waves of enemies with ease. In her second slot, this Nova Pirate holds on to the power of Eskalade in a special ring, known as Soul Ring, transforming her into Angelic Buster and allowing her to use her special skills. New characters between levels 3 and 120 can level