VIFOR-PHARMA
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
IonQ Expands in EU With Slovakia’s First National Quantum Communication Network8.12.2025 13:05:00 CET | Press release
Partnering with the Slovak Academy of Sciences, IonQ bolsters national security and European quantum communications infrastructure IonQ (NYSE: IONQ), the world’s leading quantum company, through its subsidiary ID Quantique (IDQ), today announced the deployment of Slovakia’s first national quantum communication network. Developed in partnership with the Institute of Physics, Slovak Academy of Sciences (IPSAS), the new system features a resilient hybrid architecture designed to strengthen the country’s cybersecurity infrastructure and support Europe’s quantum digital programs. The Slovak Quantum Communication Infrastructure (skQCI) project represents a major milestone in Slovakia’s contribution to the European Quantum Communication Infrastructure (EuroQCI) initiative, which seeks to establish a secure quantum-resistant communication backbone covering all European Union (EU) member states and territories. By integrating quantum-safe technologies at a national scale, Slovakia will directly
Sagemcom’s SICONIA AMI2.0 Electricity Meter Family Completes Measurement Canada Certification8.12.2025 13:00:00 CET | Press release
Sagemcom, a global leader in smart Electricity, Water and GAS metering solutions, announced that its latest generation of Siconia electricity meters (2S, 12S and 25S) have received type approval from Measurement Canada, confirming compliance with Canadian standards for metering accuracy and reliability. With this certification, Siconia meters can be adopted by utilities across Canada for their AMI deployments. The Siconia meter platform provides extensive modularity in communication technologies and integrated Grid Edge Intelligence. It is engineered in accordance with leading industry standards, enabling seamless interoperability with a broad ecosystem of technology partners. Key Features and Benefits: AMI 2.0 Ready: Enables AI-powered advanced data analytics, remote configuration, and dynamic tariff management. DER Situational Awareness: Detecting and managing resources like solar PV, and EV chargers. Enhanced Operational Efficiency: Real-time monitoring and remote capabilities reduc
KKR Provides €300m Financing for Tristan Capital Partners’ EPISO 6 Acquisition of easyHotel Platform8.12.2025 13:00:00 CET | Press release
KKR, a leading global investment firm, today announced that KKR-managed funds and accounts provided c. €300 million whole loan financing to EPISO 6, a fund managed by Tristan Capital Partners, to support its recent acquisition of easyHotel, a leading pan-European budget hotel operator. The financing will also support growth initiatives for the easyHotel platform, including further advancing the platform’s expansion and investment throughout Europe, new development projects in high-demand markets and capex investment across the existing portfolio. Tristan Capital Partners, a private equity real estate firm, acquired easyHotel, one of Europe’s best-known budget hotel brands, in June 2025 through its latest opportunistic Fund, EPISO 6, in a transaction valued at more than €400 million. The hotel chain focuses on providing affordable, efficient and well-located accommodation for leisure and business travelers. “The easyHotel portfolio combines broad geographic diversification with a proven
IBMI SNQ and ICHOM Forms Strategic Partnership in Asia, Advancing Patient-centered Healthcare in the Region8.12.2025 12:00:00 CET | Press release
The Symbol of National Quality (SNQ), initiated by Taiwan’s Institute for Biotechnology and Medicine Industry (IBMI), has partnered with the International Consortium for Health Outcomes Measurement (ICHOM) to set a new benchmark for healthcare standards across the Asia-Pacific region. The partnership agreement, signed by Chen Wei-Jao, Chief Convener, SNQ Committee, and Jennifer L. Bright, President and CEO of ICHOM, marked a significant collaboration between IBMI SNQ and ICHOM. IBMI SNQ has implemented a rigorous three-stage review system that emphasizes structure, process, and outcomes in recognizing medical teams with world-class achievements. These include liver transplantation, pancreatic cancer surgery, craniofacial reconstruction, atrial fibrillation care, critical care, and gene therapies for rare diseases. Such accomplishments have positioned Taiwan as a global benchmark for healthcare quality, with several treatment protocols adopted into textbooks and incorporated into revisi
Helical Fusion Signs Japan’s First Power Purchase Agreement for Fusion Energy with Aoki Super8.12.2025 10:00:00 CET | Press release
Agreement signals growing market demand for stable, continuous, net-electricity fusion power based on the Helical Stellarator Helical Fusion Co., Ltd. (Headquarters: Tokyo, Japan; “Helical Fusion”), a company developing a commercially viable Helical Stellarator power plant under its “Helix Program”, has signed a Power Purchase Agreement (PPA) with Aoki Super Co., Ltd. (Headquarters: Aichi, Japan; “Aoki Super”), a major regional supermarket chain in central Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207372064/en/ Takaya Taguchi (left), CEO of Helical Fusion Co., Ltd. , and Masayuki Kono (right) Managing Director and Head of Administration Division of Aoki Super Co., Ltd. at the press conference held on December 8, 2025 This marks the first fusion-energy PPA ever signed in Japan, representing a concrete step forward in the real-world adoption of fusion energy and signaling growing demand-side engagement in the em
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