Latest news with #ESKD
Business Wire
5 days ago
- Business
- Business Wire
Cadrenal Therapeutics Announces Clinical Trial Initiation Plans for Tecarfarin in Patients with End-Stage Kidney Disease (ESKD) Transitioning to Dialysis
PONTE VEDRA, Fla.--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is planned to begin later this year and will include patients with and without atrial fibrillation (AFib). There is a critical need for safe, effective anticoagulants for use in ESKD patients. Tecarfarin's orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. Share Patients with severe kidney disease are already at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality. 'There is a critical need for safe, effective anticoagulants for use in ESKD patients,' said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. 'Tecarfarin's orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. This study will be an important step forward for the continued development of tecarfarin in ESKD and in other areas with real opportunities to improve patient outcomes with a potentially better vitamin K antagonist.' Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation. 'Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need,' said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy specifically. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven. Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). The company has submitted an Orphan Drug Designation Request to the US FDA for patients with chronic kidney disease who have an implanted mechanical heart valve (and consequently require lifelong anticoagulation with a VKA) who also have genetic predisposition to impaired CYP2C9 metabolism, and resulting associated challenges with achieving reliable degrees of anticoagulation with the long-term use of warfarin. Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potentially,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; initiation of registration trial in patients with ESKD and AFib, developing transformative therapeutics to specifically address limitations of current anticoagulation therapy; addressing a critical current treatment gap in patients with ESKD; enrollment in the planned clinical trial beginning later this year; the planned study being an important step forward for the continued development of tecarfarin in ESKD; improving patient outcomes with a potentially better vitamin K antagonist; tecarfarin offering potential promise in patients initiating dialysis; addressing the unmet needs in anticoagulation therapy; and Cadrenal's ability to pursue business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to specifically address limitations of current anticoagulation therapy; the ability to address a critical current treatment gap in patients with ESKD; the ability to advance an innovative solution to address the unmet needs in anticoagulation therapy; the ability to initiate and successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Health Line
20-05-2025
- Health
- Health Line
Causes of Pain in Renal (Kidney) Failure and Management Tips
Causes of pain Management Takeaway Most people with kidney failure experience pain, most often in their bones and muscles. But the pain is usually due to a complication of kidney failure. It may also be due to the type of treatment. Kidney failure occurs when your kidneys no longer function well enough to meet your body's needs. It is also known as end stage kidney disease (ESKD) or end stage renal disease (ESRD). About 60% to 70% of people with advanced chronic kidney disease (CKD) experience pain. And just about all people in the hospital with CKD experience pain as a symptom. This article explores common causes of pain associated with kidney failure. Acute vs. chronic renal failure There are two types of renal failure: acute and chronic. Acute renal failure occurs when the kidneys fail or stop working suddenly. It's common among people receiving treatment in the hospital for other serious health conditions, such as a heart attack or pneumonia. The damage from acute kidney failure may be reversible, and symptoms such as pain may go away following treatment. Causes of pain in renal failure Pain is a common symptom of kidney failure. Some of the causes of pain linked to kidney failure include: Mineral and bone disorder Mineral and bone disorder is a common complication of CKD. It is especially common among people who have kidney failure and receive dialysis. Mineral and bone disorders don't always cause symptoms. But as it progresses, it can cause aching in your bones and joints. Calcific uremic arteriolopathy Also known as calciphylaxis, calcific uremic arteriolopathy (CUA) is a rare but serious condition that occurs among people with ESRD. It causes painful lesions to form on the surface of your skin. CUA is more common among people assigned female at birth who also have other health conditions, such as diabetes and obesity. Peripheral neuropathy CKD and ESRD can damage the nerves that travel from your brain and spinal cord to other areas of your body. This condition is known as peripheral neuropathy. Peripheral neuropathy may trigger changes in sensation, including pins and needles, numbness, and pain in the extremities. Pericardial diseases The pericardium is a thin sac filled with fluid that protects your heart, including the roots of the major blood vessels that stem from your heart. Heart conditions linked to ESRD include: uremic pericarditis pericardial effusion constrictive pericarditis Each condition causes chest pain that feels worse when you inhale. Autosomal dominant polycystic kidney disease Some types of primary kidney disease are associated with increased pain symptoms. In particular, autosomal dominant polycystic kidney disease (ADPKD) is a genetic condition that causes kidney cysts. Pain is a common symptom. It may be due to: infected, bleeding, or ruptured kidney cysts cyst growth urinary tract infections kidney stones Dialysis Although dialysis is an important treatment, it can also be a source of pain in kidney failure. Some people who undergo dialysis report muscle cramps, bloated abdomen, and pain at the insertion site of the needle. Underlying diseases People with kidney failure are more likely to have coexisting health conditions that may cause pain. Some coexisting health conditions that studies have linked to pain in kidney failure include: diabetic neuropathy ischemic peripheral artery disease osteopenia osteoporosis How to manage pain with renal failure There are many options for managing pain associated with renal failure. Usually, the treatment depends on the cause, type, frequency, and intensity. Talk with your healthcare team if you have pain associated with renal failure. Possible treatments include medication and behavioral and physical therapies. Medications for pain linked to renal failure include: acetaminophen gabapentinoids some opioids, such as buprenorphine or hydromorphone serotonin-norepinephrine reuptake inhibitors (SNRIs) topical analgesics tricyclic antidepressants Many of the above medications will require a doctor to adjust the dose, as renal failure can alter the concentration and effect of the drugs. Some opioids, like codeine and morphine, are not safe for people with CKD. Although research into their effectiveness is limited, other possible treatments for pain linked to renal failure include behavioral and physical interventions, such as: acupuncture biofeedback cognitive behavioral therapy (CBT) exercise meditation physical therapy yoga Resources for support Chronic and untreated pain linked to kidney failure can significantly affect your quality of life. It's also linked to symptoms such as depression and anxiety. The Centers for Disease Control and Prevention (CDC) provides a list of educational resources for people with CKD. The National Kidney Foundation offers a list of care providers, services, and educational materials for people living with kidney disease and their families. The American Kidney Fund offers several financial assistance programs for people who have kidney failure. Takeaway Pain is a common symptom among people with ESRD. Although kidney failure doesn't necessarily cause pain, it is associated with several other complications that do. Pain treatments include medication and behavioral or physical therapy. Your treatment will likely depend on the cause of your pain. A healthcare professional can suggest the best treatment options for you. You can promote good kidney health with a nutritious diet, getting enough sleep, exercising, and seeking treatment for underlying conditions such as diabetes or high blood pressure.
Time of India
02-05-2025
- Health
- Time of India
Why do some patients need a transplant after kidney dialysis ?
Kidney disease is a common health condition, affecting thousands of individuals every year. The severity of kidney disease is variable, while those with mild to moderate renal dysfunction can be managed with medications , patients with severe renal dysfunction may need renal replacement therapy like dialysis . Kidney damage can be temporary like in Acute Kidney Injury (AKI) where the kidney damage is due to a reversible cause like dehydration or toxins – In such patients with severe renal damage dialysis is a temporary measure till the renal function recovers. Such patients do not need a renal transplant. However patients with Chronic Kidney Disease (CKD) who have had a progressive worsening of their renal functions may progress to End Stage Kidney Disease (ESKD) – Such patients will need regular dialysis as their renal functions are unlikely to recover. In patients with ESKD, Renal transplant is the best available treatment modality as the new kidney replaces the renal function of the non functioning kidneys and the patient does not need dialysis after renal transplant. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Your Finger Shape Says a Lot About Your Personality, Read Now Tips and Tricks Undo In other words patients with ESKD need to be on dialysis until they can undergo a renal transplant. Some patients who are very ill may not be fit for a renal transplant and hence may be managed with dialysis only. However the Achilles heel of renal transplant is the availability of suitable renal donor. A living donor must ideally be related to the patient and have same blood group as the patient or have O group blood. Moreover the donor must have no chronic illness like diabetes and be fit enough to lead a normal life with single kidney after donating one kidney – hence a living renal donor undergoes a battery of tests to evaluate fitness for renal donation. Patients who do not have a suitable living renal donor may be considered for a cadaveric donor. However the number of patients on waitlist for transplant far outnumbers the number of available cadaveric donors. Though the awareness about cadaveric organ donation is improving among the general public due multiple government and media interventions – still more activity is needed in this area. Dialysis or Kidney Transplant? Choosing whether you should go for dialysis or kidney transplant in ESKD is based on several factors . For instance, dialysis is more suitable as an immediate treatment for failed kidneys. It is a non-surgical procedure and does not depend on donor availability. Moreover, it is the best treatment modality for ESKD individuals who do not fall in the safe category for getting a transplant. Alternatively, kidney transplant is ideal for people suffering from ESKD who are looking for more effective and long-term solution and have a suitable renal donor. Bottomline: A patient with temporary kidney damage (AKI) needs dialysis till the time the kidney recovers on treatment of the underlying cause of AKI. However a patient with ESKD will need dialysis until they undergo renal transplant – provided they get a suitable renal donor (live or cadaveric) and is fit for the surgical procedure. (Article courtesy: Dr. Navinath M MD(Med), DM(Nephro), DNB(Nephro), MNAMS, Consultant Nephrologist and Renal Transplant Physician, Asian Institute of Nephrology and Urology, Nungambakkam, Chennai.) Infected kidneys hold promise for transplants
The Hindu
26-04-2025
- Health
- The Hindu
As India's kidney transplant gap widens, experts call for donor pool expansion
Every week, Imran Ali* travels over 30 kilometres to a dialysis centre, a routine that has kept him alive for nearly three years. Each session costs around ₹3,500, and when combined with medication and travel, his monthly medical expenses soar to ₹70,000–₹80,000. For Imran and his family, it's a relentless cycle of financial and emotional stress. 'We've sold land, borrowed from relatives, and still, I'm waiting for a transplant,' says Imran, who is currently at number 41,000 in a waiting list of over 2 lakh kidney transplant applicants in India. 'I was told not to expect a call anytime soon. I don't even know if I'll live long enough to move ahead in the list.' Imran's doctors have warned that he may not survive more than three months without a transplant. Imran's story is not unique. It reflects the reality of thousands of people across India suffering from end-stage kidney disease (ESKD), trapped in a system where need drastically outweighs availability. According to data from the National Organ and Tissue Transplant Organization (NOTTO), kidney transplants are among the most sought-after and performed procedures in India. Experts suggest that addressing India's growing burden of ESKD requires a two-pronged approach: tackling the root cause of rising non-communicable diseases (NCDs) like diabetes and hypertension, and simultaneously addressing the critical shortage of organ donors. Growing need, limited response J. Amalorpavanathan ,founder-member secretary, Transplant Authority of Tamil Nadu, observes that while the demand for kidney transplants has grown exponentially, the supply has not kept pace. 'Even countries like the United States and Spain, with well-established transplant programmes, are struggling. In India, the gap is much wider,' he says. As per estimates, between two to three lakh patients require a kidney transplant annually in India. Official data lists over 92,000 patients registered for transplants, but the real number is believed to exceed 2 lakh. Of the 13,600 transplants performed annually, just 1,851 involve deceased donors. The rest are from living donors, mostly close relatives. For those without a matching family donor, the chances become slim, and the waiting period, indefinite. Limesh M., consultant nephrologist and transplant physician at Narayana Health City, Bangaluru, explains, 'The risk of death for kidney transplant recipients is less than half that for those on long-term dialysis. It also dramatically improves quality of life.' Still, only 2.4% of patients with kidney failure in India undergo a transplant. The number of patients on waiting lists increases by 10% each year, but transplants grow at just 4%, say experts. The average wait time for a deceased donor kidney is between three and five years, and prolonged dialysis, which patients have to undergo while waiting, is not only a financial burdens but also reduces post-transplant survival and quality of life. Closing the gap: deceased and cardiac death donations One of the major ways to address this shortfall, according to Dr. Amalorpavanathan, is to improve the recognition and use of organs from brain-dead donors. He also stresses the need to include marginal donors, such as those aged between 60–70 who may have suffered a stroke. 'While these kidneys may not be ideal for younger patients, they can be life-saving for older recipients. Matching marginal donors with marginal recipients is a pragmatic step,' he says. Dr. Amalorpavanathan also emphasises the importance of initiating Donation After Cardiac Death (DCD) programmes in India. 'DCD is already practiced widely in countries like the U.K. and U.S.A. With proper systems in place, this could be a respectful and viable way of increasing organ availability,' he says. In DCD, organs are retrieved from patients who experience cardiac arrest in intensive care settings. Though medically complex, this method has been proven to extend donor pools significantly in other nations, he points out. The promise of kidney swaps When deceased donor kidneys are not available, living donors -- usually family members-- offer the next best option. However, India's legal restrictions on unrelated donors, meant to prevent commercial exploitation, often limit options for patients with incompatible relatives. Sunil Shroff, consultant urologist and transplant surgeon, cites the successful case of the first swap transplant in India the that led to NOTTO's decision to have a 'uniform one nation one swap transplant programme' . Dr. Shroff emphasis the potential of swap transplants (paired kidney exchanges). 'In March 2025, two incompatible donor-recipient pairs in Chhattisgarh were successfully matched through a swap programme,' he says. 'Both donors and recipients recovered well. If supported systematically, swap programmes could increase transplant numbers by 10 to 15 percent.' This approach is particularly useful for blood group or tissue match incompatibilities, where new drug therapies and plasma exchange can be costly, as Dr. Limish adds, 'With policy and institutional support, this model could be scaled nationally. Need to expand the donor pool Dr. Limesh stresses the urgent need to expand the donor pool. He suggests that increasing public awareness, encouraging families of brain-dead patients to consider donation, and using grief counselors to sensitively guide them can help bridge this gap. He highlights that transparency, empathy, and trust-building are essential, especially at the moment of loss. 'Ultimately, we need a combination of stronger public health measures to prevent kidney failure, improved policies that enable ethical donation, and sustained community education that fosters trust,' Dr. Limesh says. ' Policy, prevention, and awareness Solving India's transplant crisis also demands a multifaceted approach that addresses prevention, policy, and public awareness. A major step forward lies in strengthening public health systems to proactively manage and prevent conditions like diabetes and hypertension, which are leading causes of kidney failure. At the policy level, refining existing laws to encourage ethical and informed organ donations while safeguarding individuals from exploitation is crucial. Equally important is transforming public perception through sustained awareness campaigns that challenge cultural taboos and promote the importance of organ pledging. As Dr. Limish emphasises, 'Innovative approaches and continued public education are key to increasing the number of living and deceased donors. Only then can we offer a second chance to the growing number of Indians silently suffering from kidney failure.' (*Name changed to protect privacy)
Associated Press
24-02-2025
- Business
- Associated Press
Fresenius Medical Care Announces Divestment of Select Laboratory Assets to Quest Diagnostics
Quest to provide comprehensive dialysis-related laboratory and water testing services to Fresenius Medical Care owned and affiliated clinics in the United States BAD HOMBURG, Germany and SECAUCUS, N.J., Feb. 24, 2025 /PRNewswire/ -- Fresenius Medical Care (XETRA: FME; NYSE: FMS), the world's leading provider of products and services for individuals with renal disease, and Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that, under terms of a definitive acquisition agreement, Quest will acquire select assets of FME's wholly owned Spectra Laboratories, a leading provider of renal-specific laboratory testing services in the U.S. In addition, under a separate agreement, Quest will provide comprehensive laboratory services related to end-stage kidney disease (ESKD) and specialized water testing for patients and providers served by dialysis centers operated by Fresenius Medical Care and its wholly owned and joint-venture partners in the United States. By acquiring select laboratory assets from FME, Quest will add dialysis-related water testing, a new capability, to Quest's comprehensive portfolio. The arrangement will enable FME to gain operational efficiencies and allow FME and other providers and patients at dialysis clinics to benefit from Quest's clinical leadership and diagnostic innovation in chronic kidney disease and transplantation services. It will also leverage Quest's national scale, as multiple Quest laboratories spread across the U.S. will provide testing for nearby dialysis clinics, reducing transportation time and speeding results reporting for some test services. Quest expects to perform testing across several of its laboratories during lower-volume daytime hours, optimizing the return on capital invested into its laboratory network. Financial terms were not disclosed. The acquisition is expected to close in the second half of 2025, pending customary state regulatory reviews. The transition of services is expected to be complete by early 2026. 'This transaction is part of our comprehensive portfolio optimization strategy to drive operational efficiencies and will provide enhanced experiences for patients and our clinical employees by integrating Quest Diagnostic's industry-leading expertise in laboratory medicine into our dialysis centers. This agreement is a step forward to allow us to remain focused on our core business of providing world-class dialysis care to every patient, every day,' said Helen Giza, Chief Executive Officer of Fresenius Medical Care. 'Much like Fresenius Medical Care, Quest Diagnostics is passionate about creating a healthier future for patients. These shared values, along with Quest's proven track record for quality care and service, make us confident that they are the right company to continue to deliver a high-quality experience to our patients, physician partners, and clinical staff.' 'Our relationship with Fresenius Medical Care will extend our industry-leading test portfolio in chronic kidney disease, one of the nation's most prevalent chronic diseases, to include dialysis-related laboratory and water testing,' said Jim Davis, Chairman, CEO and President, Quest Diagnostics. 'It will also optimize Quest's national scale to bring high-quality laboratory services closer to FME's dialysis clinics and the patients under their care across the United States.' Fresenius Medical Care recently successfully finished year two of a three-year strategic turnaround and transformation plan. Focusing on businesses and markets with the best strategic fit and greatest scale and sustainable profitable growth potential, Fresenius Medical Care is continuing to execute against its portfolio optimization plan to divest non-core and dilutive assets. Chronic kidney disease affects about 35.5 million people, or 14%, of the U.S. population, making it one of the nation's 10 most prevalent and costly chronic diseases in the U.S. Up to 9 in 10 adults who have CKD are not aware that they have the disease. Once the disease has progressed to end-stage kidney disease (ESKD), patients typically require transplant or dialysis. More than 800,000 people in the U.S. receive dialysis. Dialysis requires periodic lab testing to manage the disease as well as testing water for contaminants. About Fresenius Medical Care: Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 4.1 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,732 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 308,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS). For more information visit the company's website at About Quest Diagnostics Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our more than 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. Disclaimer: This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this release. FME Media contact Christine Peters T +49 160 60 66 770 [email protected] FME Contact for analysts and investors Dr. Dominik Heger T +49 6172 609 2601 [email protected] Quest Media contact Jen Petrella T +1 973-520-2800 [email protected] Quest Contact for analysts and investors Shawn Bevec T +1 973-520-2900
