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
KiddeFenwal Launches New Website and Information Hub8.7.2026 18:00:00 CEST | Press release
Enhanced digital platform reflects KiddeFenwal’s legacy, stature and growth trajectory in the fire suppression and safety controls industry KiddeFenwal, the global leader in the fire suppression and safety controls industry, today unveiled a revitalized website, designed to serve as a comprehensive information hub for fire industry practitioners and customers alike. The modernized platform includes features created specifically with the company’s global partners, OEMs and distributors in mind, including: Accelerated asset navigation, pointing users to critical safety documentation, design parameters and product specifications; Seamless solution mapping, helping users quickly locate fire suppression configurations by industry, from data centers to BESS applications to commercial kitchens; and Enhanced resource access, including streamlined pathways to connect with the company’s elite distributor network across 120 countries. It also provides information about the company’s three brands,
Dryad Networks Reaches XPRIZE Wildfire Finals Milestone, Demonstrating Autonomous Detection and Suppression of Wildfires in Alaska8.7.2026 17:00:00 CEST | Press release
Dryad Networks, the leader in ultra-early wildfire detection technology, today announced a major achievement in the finals of the Autonomous Wildfire Response track of XPRIZE Wildfire, a four-year, $11 million global competition accelerating new solutions to end destructive wildfires. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707802818/en/ The Silvaguard Suppression Drone can deliver a 100 liter liquid suppressant to autonomously suppress small wildfires detected by Silvanet Competing against just two other finalists selected from an original field of nearly 300 teams worldwide, Dryad successfully demonstrated the integrated capabilities of its Silvanet wildfire detection network and Silvaguard autonomous firefighting drone system during final testing in remote Alaska. The XPRIZE Wildfire finals challenged teams to autonomously detect and suppress a wildfire without any human intervention across a vast 1,000 square k
Rigaku Opens "Rigaku Solutions Center Osaka" to Strengthen Global Semiconductor Metrology Service Capabilities8.7.2026 17:00:00 CEST | Press release
- Centralizing and Expanding Practical Training to Strengthen Global Service Capabilities - Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), has opened the Rigaku Solutions Center Osaka (RSC-Osaka) at its Osaka Plant. The new facility centralizes and expands practical training for field service engineers supporting semiconductor metrology systems, strengthening Rigaku's global service capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708402770/en/ Photo: Hands-on training using the TXRF-V310 at RSC-Osaka As semiconductor manufacturing processes continue to advance toward finer geometries, higher layer counts, and more complex three-dimensional structures, semiconductor metrology systems require ever greater precision and operational stability. X-ray analytical technologies pl
Cardiac Dimensions® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System®8.7.2026 16:05:00 CEST | Press release
New data highlight multi-center 5-year durability, 10-year survival, and the largest single-center experience across both HFrEF and HFpEF patients with functional mitral regurgitation Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707656796/en/ Carillon Mitral Contour System® The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mi
First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders8.7.2026 15:00:00 CEST | Press release
Trial reports correlations between ketone levels and cognitive and psychiatric symptoms in individuals with schizophrenia-spectrum and bipolar-1 disorders Published today in Schizophrenia Bulletin, a first-of-its-kind randomized controlled trial (RCT) from researchers at the University of California, San Francisco (UCSF), and funded in part by the National Institute of Mental Health (NIMH), adds to growing literature on the potential benefit of a ketogenic diet for treating psychotic disorders. The study, which enrolled participants with schizophrenia-spectrum or bipolar-1 disorders, demonstrated rapid metabolic improvements with a ketogenic diet compared to diet-as-usual during an initial one-month RCT open-label phase. Furthermore, those who continued with the optional four-month single-arm ketogenic diet extension saw meaningful gains across metabolic, psychiatric, and cognitive measures. This press release features multimedia. View the full release here: https://www.businesswire.co
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