Due to the clear positive effect shown in patients with chronic kidney disease, the EMPA-KIDNEY phase III clinical trial of Otani® (empagliflozin) will be terminated early

Following a formal interim review, the Independent Data Monitoring Committee recommends early termination of the EMPA-KIDNEY clinical trial EMPA-KIDNEY is the largest and most extensive clinical trial of an SGLT2 inhibitor in chronic kidney disease to date Detailed results from the clinical trial are expected this year LATER ANNOUNCEMENT The Oxford Medical Research Council (MRC) Population Health Research Unit, Boehringer Ingelheim and Eli Lilly & Company (NYSE: LLY) announced that the EMPA-KIDNEY Clinical The trial evaluating empagliflozin in adults with chronic kidney disease (CKD) will be terminated early
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The decision was made after a formal interim review that met prespecified positive efficacy criteria
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As the largest clinical trial to date of an SGLT-2 inhibitor for CKD, EMPA-KIDNEY is evaluating the efficacy and safety of empagliflozin in adult patients with CKD in a population of SGLT2 inhibitors that are common in clinical practice but have previously Adult patients with CKD are underrepresented in a clinical trial designed to address a critical unmet clinical need
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Populations included in the clinical trial included:[1],[2] mild to severe reduction in eGFR (a measure of kidney function); normal and elevated levels of albumin (a protein present in urine); with and Without diabetes; CKD due to a wide range of underlying causes EMPA-KIDNEY was a large, double-blind, randomized, placebo-controlled, academic-led clinical trial of more than 6,600 adults with CKD
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[2] The trial was independently conducted, analysed and reported by the MRC Population Health Research Unit at the University of Oxford
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The primary endpoint of the trial was a composite of renal disease progression* or cardiovascular death
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Key secondary outcomes included cardiovascular death or hospitalization for heart failure, all-cause hospitalization, and all-cause mortality
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[2] "Chronic kidney disease kills 5 to 10 million people worldwide each year, and the lives of many are severely affected by frequent dialysis treatments," said William University of Oxford, Population Health Clinician Scientist, Honorary Consultant in Nephrology, and EMPA-KIDNEY Co-Principal Investigator Associate Professor Herrington said
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"Our goal in conducting this study in a broad range of patients with reduced renal function is to delay the need for dialysis and prevent the development of heart disease as much as possible
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" Patient benefit," said co-principal investigator Professor Richard Haynes
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"We are very grateful to all the participants who made this trial possible and look forward to sharing detailed trial results later this year
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" Kidney disease is a global public health problem that affects nearly 850 million people, accounting for 10 percent of adults more than one tenth
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[3],[4] CKD is the leading cause of death worldwide and doubles the risk of hospitalization for patients
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[5],[6] Furthermore, CKD is closely associated with various metabolic and cardiovascular diseases, such as diabetes, hypertension and obesity
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[7],[8] “As part of our commitment to helping millions of people with chronic kidney disease, the early termination of the EMPA-KIDNEY clinical trial brings us closer to achieving this goal faster,” said Boehringer Ingelheim Vice President said Waheed Jamal, MD, President and Head of Cardiometabolic Medicine
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"EMPA-KIDNEY further underscores the success of the EMPOWER trial program, which has demonstrated cardiorenal metabolic benefits of empagliflozin in millions of patients worldwide
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" Full results from the EMPA-KIDNEY clinical trial will be presented in an upcoming medical Announced at the conference
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"EMPA-KIDNEY enrolled a broad range of adults with kidney disease who were excluded from or did not meet inclusion criteria in previous trials focused on SGLT2 inhibitors to slow the progression of kidney disease," said Jeff Emmick, MD, vice president of product development at Eli Lilly
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"The early discontinuation of clinical trials is a major step toward our goal of improving the lives of adult patients with kidney disease
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" EMPA-KIDNEY follows the landmark EMPA-REG OUTCOME® and EMPEROR clinical trials, all of which The cardio-renal benefits of empagliflozin have been demonstrated
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[9],[11],[12] EMPA-REG OUTCOME is the first cardiovascular outcome trial of an SGLT2 inhibitor to show that the use of empagliflozin in addition to standard care can lead to type 2 diabetes with established cardiovascular disease Patients benefited both in cardiovascular and renal** outcomes
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[10] In addition, a subgroup analysis of the EMPEROR trial showed that empagliflozin demonstrated cardiorenal benefit in adult patients with chronic heart failure, regardless of patient ejection fraction
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[10],[11] The EMPA-KIDNEY trial is part of the EMPOWER clinical program, the most extensive and comprehensive clinical research program of any SGLT2 inhibitor, to explore the effects of empagliflozin on various cardio-renal- Impact on the lives of patients with metabolic diseases
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*Defined as end-stage renal disease (starting maintenance dialysis or receiving kidney transplantation), persistent decline in eGFR to less than 10 mL/min/1.
73 m2, renal death after randomization, or persistent decline in eGFR of at least 40%
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**Pre-specified secondary exploratory endpoint: 39% relative risk reduction for renal disease events or worsening
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Defined as progression to macroalbuminuria, doubling of serum creatinine (with eGFR [MDRD] ≤ 45 mL/min/1.
73 m2), initiation of renal replacement therapy, or death from renal disease
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eGFR assesses glomerular filtration rate; MDRD: dietary changes in renal disease
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References [1] Herrington WG, Preiss D, Haynes R, et al.
The potential for improving cardio-renal outcomes by sodium-glucose co-transporter-2 inhibition in people with chronic kidney disease: a rationale for the EMPA-KIDNEY study.
Clin Kidney J.
2018;11(6):749–61.
[2] The EMPA-KIDNEY Collaborative Group.
[Published online ahead of print March 3 2022].
Nephrol Dial Transplant.
2022.
DOI:10.
1093/ndt/gfac040.
[3] Li PKT, Garcia-Garcia G, Lu SF, et al.
Kidney health for everyone everywher – from prevention to detection and equitable access to care.
Braz J Med Biol Res.
2020;53(3):e9614.
[4 ] Luyckx VA, Al-Aly Z, Bello AK, et al.
Sustainable Development Goals relevant to kidney health: an updat on progress.
Nature Reviews Nephrology.
2021;17:15–32.
[5] Neuen BL, Chadban SJ, Demaio AR, et al.

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[12],[13] Notably, chronic kidney disease increases morbidity and mortality
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Most people with chronic kidney disease die from cardiovascular complications, which usually precede end-stage renal disease
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[14],[15] Once end-stage renal disease progresses, patients must undergo renal replacement therapy, such as chronic dialysis or kidney transplantation
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[16] Chronic kidney disease is very common around the world, affecting more than 10% of the population
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[14],[15] About EMPA-KIDNEY: A study of empagliflozin for cardiac and renal protection[2],[16] EMPA-KIDNEY (NCT03594110) is a study evaluating the effect of empagliflozin on renal disease progression and cardiac A multinational, randomized, double-blind, placebo-controlled clinical trial of the impact of vascular death risk on clinically relevant outcomes
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The primary outcome was time to first event of cardiovascular death or renal disease progression
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Renal disease progression refers to end-stage renal disease (requiring renal replacement therapy, such as dialysis or kidney transplantation), sustained decline in estimated glomerular filtration rate (eGFR) to <10 mL/min/1.
73 m2, renal death or after randomization eGFR continued to decline by greater than or equal to 40%
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EMPA-KIDNEY is expected to enroll approximately 6,000 patients with chronic kidney disease, with or without diabetes or proteinuria
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These patients received empagliflozin 10 mg or placebo in addition to existing standard of care
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About Oxford University Medical Research Council (MRC) Population Health Research Unit (PHRU) The Oxford University MRC PHRU (Medical Research Council) is part of Oxford Population Health and aims to improve the treatment and prevention of chronic diseases, In particular, cardiovascular and metabolic diseases (such as diabetes and chronic kidney disease), which together contribute to a large proportion of adults worldwide, are responsible for premature death and the burden of disability
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The MRC PHRU is led by Professor Colin Baigent, Co-Chairman of the EMPA-KIDNEY Steering Committee
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The MRC PHRU leads innovative clinical research and meta-analyses aimed at identifying important advances that have a significant impact on health
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Other major studies include the groundbreaking Randomized Evaluation of Therapeutics for COVID-19 (RECOVERY) trial, co-led by Professor Martin Landray, co-chair of the EMPA-KIDNEY Steering Committee
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MRC PHRU research has a global reach, covering a large number of people, providing reliable information on the cause of disease and the effect of treatment, and has a huge impact on global human health
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About the EMPOWER Project The consortium developed the EMPOWER project to explore the effects of empagliflozin on key clinical cardiovascular and renal outcomes across a range of cardio-renal-metabolic diseases
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Cardiorenal metabolic diseases are the leading cause of death worldwide, causing up to 20 million deaths each year
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Through the EMPOWER project, Boehringer Ingelheim and Eli Lilly are working to increase understanding of these interconnected systems and develop treatments that provide comprehensive, multi-organ benefit
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Comprising 8 studies and 2 real-world studies, EMPEROR reinforces the alliance's long-term commitment to improving clinical outcomes for patients with cardio-renal-metabolic diseases
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With clinical studies enrolling more than 400,000 adult patients worldwide, EMPOWER is the most extensive and comprehensive clinical research program on SGLT2 inhibitors to date
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About Heart-Kidney-Metabolic Disease Boehringer Ingelheim and Lilly hope to change the way people are treated for heart-kidney-metabolic disease, a group of interconnected diseases that affect more than 1 billion people worldwide and are the leading cause of death
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[20] The cardiovascular, renal and metabolic systems are interconnected and share many of the same risk factors and pathological pathways across the disease spectrum
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Dysfunction in one system may accelerate the onset of other systems, leading to the development of related diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease that are interconnected, leading to an increased risk of cardiovascular death
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Conversely, improving the health of one system can have a positive impact in other systems
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[7],[17],[18] Through our research and treatments, we aim to support people's health, restore balance between the interconnected heart-kidney-metabolic systems, and reduce their risk of serious complications risk
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As part of our commitment to those whose health is compromised by cardiorenal metabolic disease, we will continue to research multidisciplinary treatment options and focus our resources on filling treatment gaps
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About Empagliflozin Empagliflozin (trade name Ou Tangjing) is an oral, once-daily, highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, and the first instruction in many countries Type 2 diabetes drugs that contain data on cardiovascular mortality risk reduction
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[19],[20] About Boehringer Ingelheim and Eli Lilly In January 2011, Boehringer Ingelheim and Eli Lilly announced a cooperation agreement, which includes several varieties of hypoglycemic drugs
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Based on different markets, the two parties will choose to jointly promote or individually promote the drugs provided by each of them for this cooperation
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This collaboration brings together the strengths of two leading global pharmaceutical companies focused on patient needs, and by working together, the two companies are committed to helping people with diabetes and exploring solutions to their unmet medical needs
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Clinical trials evaluating empagliflozin in patients with heart failure or chronic kidney disease have been initiated
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