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
Robbyant Releases LingBot-Touch to Bring General-Purpose Touch Perception to Robots10.11.2026 10:23:00 CET | Press release
Robbyant, an embodied AI company within Ant Group, today announced the open-source release of LingBot-Touch, a tactile foundation model that gives robots a critical missing sense by enabling robust touch perception. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109284905/en/ LingBot-Touch encodes magnetic tactile, visual tactile, and piezoresistive signals into unified tactile tokens for use by different action models. Pre-trained on nearly 5,000 hours of real-world tactile data, the model covers three mainstream sensing modalities—magnetic tactile, visual tactile, and piezoresistive sensing—and translates their diverse signals into a unified tactile representation. This allows different dexterous hands and action models to share and reuse tactile understanding, enabling robots to not only “see clearer” and “think deeper,” but also “feel sharper” during fine manipulation tasks, such as turning pages, unscrewing bottle ca
Wise Selects Navan to Modernize Global Travel Program10.11.2026 10:00:00 CET | Press release
Global financial technology company plans to improve traveler choice, cost control and visibility Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced that Wise (Nasdaq:WSE, LSE:WISE), the global financial technology company building the best way to move and manage the world's money, has selected Navan to manage its business travel program. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261109603155/en/ Global financial technology company plans to improve traveler choice, cost control and visibility “Our teams travel across the world to work together and support our customers, so it's important that booking and managing travel is straightforward,” said Hanro Hennig, VP Global Real Estate, Workplace and Risk at Wise. “We're working with Navan to make that experience simpler, while giving us better visibility and control over travel costs.” Key anticipated benefits of the partnershi
Quectel Launches EG216Q-GL and BG950Q-GL to Give IoT Device Makers a More Cost-efficient, Lower-power Upgrade Path10.11.2026 10:00:00 CET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced the EG216Q-GL and BG950Q-GL, two next-generation global cellular IoT modules based on Qualcomm technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110650568/en/ Quectel launches EG216Q-GL and BG950Q-GL to give IoT device makers a more cost-efficient, lower-power upgrade path Built in Quectel’s widely adopted EG2 and BG95 form factors, the modules give device makers a direct route from established legacy platforms to a more cost- and power-optimized generation. Customers can reuse the board designs and development work they already have. The EG216Q-GL is an LTE Cat 1bis module for customers whose designs use Quectel’s EG2-footprint modules. These include the EC2x series, EC200A series, EG25-G, EG25-GL, EG21-G and EG21-GL, as well as the UC200A-GL. Because it shares their form factor, manufacturers can upgrade while keeping their
Heitman Partners with Talliosake to Establish Nordic Drive-Up Self-Storage Platform Talli10.11.2026 10:00:00 CET | Press release
Since 1996, Heitman has invested over $15 billion in 1,600 self-storage properties across 14 countries Heitman LLC (“Heitman”), a global real estate investment management firm, today announced the launch of Talli, a new Nordic drive-up self-storage platform established through the acquisition of the majority of Talliosake Oy’s (“Talliosake”) rental operating business. Talliosake will remain a minority investor in Talli. Completed on behalf of Heitman’s European value strategy, the transaction establishes a platform for expansion across Finland and Sweden and builds on Heitman’s Nordic self-storage presence following its acquisition of the Servistore platform in Sweden in 2024. The Talli platform brings together the experienced management team that has driven Talliosake’s growth with Heitman’s global investment and operational capabilities. Since 2010, Talliosake has delivered more than 6,400 drive-up self-storage units across 230 properties in Finland and Sweden, building deep expertis
OBI Group Will Adopt Blue Yonder Solutions to Unify Demand Planning and Replenishment Across 660+ European Stores10.11.2026 09:00:00 CET | Press release
Germany-based Home and Garden retailer replaces multiple systems with a single AI-driven planning platform spanning 10 countries OBI Group, a leading European Home and Garden retailer, has begun adopting Blue Yonder Demand Planning and end-to-end replenishment capabilities across its stores and distribution centers, with plans to ultimately deploy them to more than 660 stores across all of its markets. The deployment replaces multiple systems with a single, scalable platform. It also gives OBI AI-enabled forecasting and automated replenishment from distribution centers to store shelves, improving product availability for millions of customers across Europe. OBI selected Blue Yonder to consolidate fragmented planning systems into one integrated platform. That helps improve forecast accuracy across assortment types and planning timeframes while standardizing forecasting and replenishment processes across its network. Blue Yonder’s machine-learning capabilities and the prospect of future
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