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
Owkin Creates New Spin out Waiv, Formerly Owkin Dx, With $33M Financing12.3.2026 14:30:00 CET | Press release
Investment lead by OTB Ventures and Alpha Intelligence CapitalWaiv develops AI-powered precision testing to better identify and stratify patients in the clinic and in clinical trials, transforming patient careWaiv extends Owkin’s strategy of real-world validation for its AI Owkin, the AI company on a mission to solve the complexity of biology, today announced the spin out of Waiv, formerly known as Owkin Dx. The move follows significant investor interest and positions Waiv to bring AI-powered precision testing for better identification of patients in the clinic and in clinical trials, to transform patient care. This follows on from the successful launch of Bioptimus, an Owkin incubated company, in February 2024. Waiv translates AI innovation into real-world clinical impact, developing tests that predict biomarkers and patient outcomes, including RlapsRisk BC for prognostic risk profiling. With multiple tests already in use in clinical settings, its deployment platform Destra, and colla
RQM+ Launches SMART Solutions Life Cycle Partnership Model12.3.2026 14:30:00 CET | Press release
Helps MedTech Companies Navigate MDR, IVDR, and AI-Enabled Device Development RQM+, a leading MedTech CRO offering regulatory consulting, clinical trial, laboratory, and reimbursement services, today announced the launch of SMART Solutions, a life cycle partnership model designed to help medical device and diagnostics companies manage growing regulatory and development complexity. SMART Solutions introduces a strategy-led operating framework that unifies regulatory, quality, clinical, reimbursement, and laboratory expertise to support MedTech companies across the entire product life cycle to help reduce risk from early development through post-market. “MedTech companies are navigating unprecedented complexity as regulatory expectations evolve, product innovation accelerates, and post-market expectations are expanding,” said John Potthoff, Ph.D., chief executive officer of RQM+. “SMART Solutions moves beyond traditional consulting by providing an integrated life cycle partnership that h
Cryptio Raises $45m Series B as Digital Assets Move Into Regulated Financial Markets12.3.2026 14:06:00 CET | Press release
The system of record for tokenized finance – ERP infrastructure for institutions operating in digital assets Cryptio, a leader in financial data transformation and enterprise resource planning (ERP) applications for regulated digital assets, announced today a $45 million Series B funding round co-led by BlackFin Capital Partners and Sentinel Global, with participation from 1kx, Alven, BlueYard Capital and Ledger Cathay Capital. Banks, exchanges, asset managers, including Société Générale’s SG Forge, Circle, Gemini, and Securitize rely on Cryptio to ensure financial integrity across their digital assets businesses. Existing ERP systems fall short for digital assets Traditional ERP and accounting systems were not designed for blockchain-native assets, real-time reporting, or modern custody frameworks. As regulated financial institutions expand into stablecoins, tokenized securities and other on-chain instruments, these limitations create material operational and reporting challenges. Cry
HyperLight Introduces 145 GHz Reference Modulators to Enable 448Gbps per Lane Datacom and 260GBaud Telecom Development12.3.2026 14:03:00 CET | Press release
HyperLight Corporation, creator of the TFLN Chiplet™ platform, today announced the release of its 145 GHz Packaged Intensity Modulator (IM), expanding the company‘s high-speed modulator portfolio. The new device is designed for ultra-wide modulation bandwidth, high signal fidelity, and stable operation control, enabling 448 Gbps per lane intensity-modulated-direct-detection (IMDD), 260 GBaud coherent links, and broadband RF photonics systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312319685/en/ Fig. 1: HyperLight’s 145 GHz intensity modulator for 448Gbps per lane IMDD and 260GBaud coherent applications, with operational electro-optical bandwidth >145GHz, stable bias control, 0.8 mm-connector; available in O-, C-, and L-bands. As symbol rates and analog bandwidth requirements continue to rise across data center interconnects, AI-driven photonics infrastructure, and laboratory test environments, system architects in
Enodia Therapeutics Strengthens Sec61 Portfolio Through Acquisition of Preclinical Assets from Kezar Life Sciences12.3.2026 14:00:00 CET | Press release
Transaction deepens insights into Sec61 selectivity for targeted protein degradation, supporting accelerated development of Enodia’s novel small-molecule inhibitors Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, and Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today announced that Enodia has acquired Kezar’s assets from its Sec61-based discovery and development program. The acquisition enables Enodia to advance its understanding of Sec61 selectivity mechanisms, expanding biological and translational insights for faster progression toward key clinical milestones. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260312627573/en/ Under the terms of the purchase agreement between Enodia and Kezar, Kezar w
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