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
Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4*12.11.2026 23:07:00 CET | Press release
The multi-level takeover includes a Throne Room, interactive photo opportunities, special lighting, and more The Empire State Building (ESB) is the gateway to Mount Olympus in Percy Jackson’s world, and now fans can experience the magic like never before. On Nov. 16, the Empire State Building Observation Deck (ESBOD) will unveil “Olympus Awaits,” a multi-level “Percy Jackson and the Olympians” takeover, in partnership with Disney+. The immersive takeover – included with every Observation Deck ticket – will feature an epic Throne Room, interactive photo opportunities, surprise giveaways, ESB x “Percy Jackson” merch, and more, available through Dec. 4, 2026.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112442266/en/ Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4* “This immersive NYC experience
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 18:09:00 CET | Press release
Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks
WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network12.11.2026 18:00:00 CET | Press release
New feature lets members follow friends and family, share performance and health insights, and celebrate life's moments together WHOOP, the human performance brand, today launched WHOOP Humans, a new feature that lets members follow friends and family, share fitness, health, and performance data they choose, and support each other's progress. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112176779/en/ WHOOP Launches WHOOP Humans, the Most Verifiably Human Social Network For more than a decade, WHOOP has helped members better understand their own health and performance. Now, WHOOP Humans extends that experience beyond the individual, making it easier to celebrate achievements, encourage progress, and look out for the people who matter most. "In a world that's becoming increasingly artificial, we're building something deeply human,” said Will Ahmed, Founder and CEO of WHOOP. “This is the most verifiably human network ever
Integrated Hubs for Green Chemistry Research Aim to Transform How Chemicals and Materials Are Designed12.11.2026 17:00:00 CET | Press release
International network will investigate fundamental principles for creating safer, higher-performing chemicals and materials The Gordon and Betty Moore Foundation today announced four Integrated Research Hubs to explore new frontiers in chemical design, from materials that respond to their surroundings to molecules designed for safety from the start. Bringing together global researchers across institutions and disciplines, the hubs will investigate fundamental principles that could enable new capabilities in chemicals and materials while improving performance and protecting human health and the environment. The research priorities emerged through extensive engagement with the scientific community to identify the questions that could transform what chemistry can achieve. Each hub will connect researchers across institutions around one of four green chemistry focus areas: Safer molecular design: Led by The George Washington University, this hub will combine artificial intelligence and qua
Roquette Highlights Scalable Excipient and Capsule Solutions for Regional and Global Pharmaceutical Markets at CPHI India 202612.11.2026 16:00:00 CET | Press release
Helping pharmaceutical manufacturers accelerate the journey from formulation to market through deep technical expertise, meaningful innovation, close collaboration and global capabilities Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, will showcase its comprehensive portfolio of excipient and capsule solutions at CPHI India 2026, Hall 1, Booth 1I12 from November 23 to 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112803410/en/ Meet Roquette at CPHI India 2026, Hall 1, Booth 1I12 At the event, Roquette will demonstrate how it helps pharmaceutical manufacturers accelerate the journey from formulation to market with confidence. By combining technical expertise, trusted quality, meaningful innovation and close collaboration, Roquette helps customers address formulation, scale-up and manufacturing challenges across a broad range of pharmaceutical application
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