VIFOR-PHARMA
24.6.2021 07:02:13 CEST | Business Wire | Press release
Regulatory News:
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.
Conference call:
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 .
About DIAMOND
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.
About hyperkalemia
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005811/en/
Link:
About Business Wire
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
Blackstone Raises its Largest Asia Private Equity Fund at $13.1 Billion2.6.2026 03:00:00 CEST | Press release
Oversubscribed Fund More than Doubles Capital Raised for Predecessor Vehicle Blackstone (NYSE: BX) today announced the final close of Blackstone Capital Partners Asia III (“BCP Asia III”) at $13.1 billion, exceeding its $10 billion target and marking the firm’s largest private equity fundraise in the region. The oversubscribed fund reached its hard cap and builds on the strong performance of the strategy’s first two vintages, with this close representing more than double the amount of capital raised for its predecessor vehicle. Joe Baratta, Global Head of Blackstone Private Equity Strategies,said: “We are grateful for the continued trust of our investors in Blackstone and our leading Asia Private Equity franchise. This successful fundraise reflects the strength of our platform and our ability to perform through cycles. Asia Pacific is the fastest-growing region in the world, presenting compelling opportunities to invest at scale behind our high-conviction themes and deliver for our inv
Phison Unlocks Full-Scale AI Deployment Across Industries2.6.2026 02:00:00 CEST | Press release
Building an Ecosystem with Pascari aiDAPTIV™ Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, today announced a new strategic initiative at COMPUTEX 2026 under the theme “AI Enabler: Evolving Data Storage Intelligence.” Expanding beyond its role as a storage technology leader, Phison is taking a systems-level approach to AI solutions spanning AI infrastructure, edge AI computing and AI software platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601070396/en/ Phison evolving data storage intelligence at COMPUTEX 2026 At COMPUTEX 2026, Phison is showcasing comprehensive AI storage and computing architecture solutions designed to address key challenges facing enterprises and end users in the AI era, including high AI deployment costs, GPU and memory limitations, data privacy concerns and the increasing storage bandwidth and power demands driven by AI workloads. Four Core Te
Phison Collaborates with Intel to Bring Larger Local AI Workloads to Intel AI PC Platforms2.6.2026 02:00:00 CEST | Press release
Phison's Pascari aiDAPTIV™ removes local memory constraints on client PCs, enabling larger MoE AI models and agentic AI applications COMPUTEX — Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, today announced a collaboration with Intel to enable AI PCs to deploy larger, more capable AI applications locally. The collaboration combines Intel® Core™ Ultra Series 3 processors with Phison’s Pascari aiDAPTIV, a memory extension solution that unblocks memory-constrained systems to support larger Mixture-of-Experts (MoE) AI models, longer-running AI sessions and agentic AI workflows. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601878925/en/ Phison and Intel collaborate to bring larger local AI workloads to Intel AI PC Platforms Today, AI PCs are moving beyond simple assistant applications toward more advanced local AI use cases. These solutions now support end users and businesses i
SymphonyAI Brings AI-Powered Assortment and Space Platform to Global CPGs, Compressing Category Review Cycles from Weeks to Days2.6.2026 00:35:00 CEST | Press release
CINDE Assortment and Space closes the loop between assortment, planogram, and in-store execution, proven across 500-plus global CPG deployments Planogram compliance failures, undetected out-of-stocks, and the lag between headquarters planning and store-level execution cost grocers measurably in comp sales, shrink, and associate labor hours. The tools built for category planning have never been designed to close that execution gap. In response, SymphonyAI, a global leader in Vertical AI, today announced the availability of CINDE Assortment and Space for CPGs, an AI platform that closes the loop between assortment strategy, planogram execution, and in-store compliance, compressing the category review cycle from four to six weeks to a matter of days. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602137061/en/ The platform is underpinned by SymphonyAI's Transferable Demand AI, a model trained across 25 years of retail data a
SymphonyAI Launches CINDE Retail Media Intelligence to Connect Merchandising and Media for Mid-to-Large Grocers2.6.2026 00:05:00 CEST | Press release
CINDE RMI connects merchandising and retail media in a single closed-loop platform — without replacing your existing retail media stack Retail media has become the fastest-growing profit line in grocery, yet the billions of dollars CPG advertisers invest in it every year flow through a system where media buyers and merchants never see the same data. Merchants plan assortments, negotiate trade spend, and execute resets with no visibility into which CPG media investments are driving category velocity, while CPG advertisers renew or walk based on incrementality proof that most retailers cannot provide. To solve for this, SymphonyAI, a global leader in Vertical AI, today announced the general availability of CINDE Retail Media Intelligence (RMI), an AI platform that connects merchandising, media, and shopper intelligence into a single closed-loop system, giving retailers and CPG partners shared visibility into how every media dollar moves category turns, trade spend ROI, and gross margin a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom