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Everything You Should Know About Stage 2 Kidney Disease
Largely asymptomatic, stage 2 kidney disease can be hard to diagnose. Some visible symptoms might include changes in urine color and dry or itchy skin.
Chronic kidney disease, also called CKD, is a type of long-term damage to the kidneys. It's characterized by permanent damage that progresses on a scale of five stages.
Stage 1 means you have the least amount of kidney damage, while stage 5 (end stage) means you've entered kidney failure. A diagnosis of stage 2 CKD means you have minor damage.
The goal of diagnosis and treatment for CKD is to stop the progression of further kidney damage. While you can't reverse the damage at any stage, having stage 2 CKD means you still have an opportunity to stop it from getting worse.
Read more about the characteristics of this stage of kidney disease, as well as the steps you can take now to help prevent your condition from going beyond stage 2.
To diagnose kidney disease, a doctor will take a blood test called an estimated glomerular filtration rate (eGFR). This measures the amount of creatine, an amino acid, in your blood, which can tell whether your kidneys are filtering wastes.
An abnormally high creatinine level means your kidneys aren't functioning at an optimal level.
EGFR readings that are 90 or higher occur in stage 1 CKD, where there's extremely mild kidney damage. Kidney failure is seen in readings of 15 or below. With stage 2, your eGFR reading will fall between 60 and 89.
No matter what stage your kidney disease is classified as, the goal is to improve overall kidney function and prevent further damage.
Regular eGFR screenings can be an indicator of whether your treatment plan is working. If you progress to stage 3, your eGFR readings would measure between 30 and 59.
EGFR readings at stage 2 are still considered within a "normal" kidney function range, so it can be difficult to diagnose this form of chronic kidney disease.
If you have elevated eGFR levels, you may also have high creatinine levels in your urine if you have kidney damage.
Stage 2 CKD is largely asymptomatic, with most noticeable symptoms not appearing until your condition has progressed to stage 3.
Possible symptoms include:
Kidney disease itself is caused by factors that decrease kidney function, resulting in damage to the kidneys. When these important organs don't work properly, they can't remove wastes from the blood and produce the right urinary output.
CKD isn't typically diagnosed at stage 1 because there's so little damage that not enough symptoms occur to detect it. Stage 1 can transition to stage 2 when there's a decrease in function or possible physical damage.
The most common causes of kidney disease include:
The longer the above conditions are left untreated, the more damage your kidneys could sustain.
Since mild kidney disease doesn't have as many noticeable symptoms as advanced stages, you may not realize you have stage 2 CKD until your annual physical.
The important message here is that adults should have an ongoing relationship with a primary care doctor. In addition to your regular checkups, you should also see your doctor if you experience any of the symptoms mentioned above.
A doctor will also likely monitor your kidney health carefully if you have any risk factors or a family history of kidney disease.
In addition to blood and urine tests, a doctor may perform imaging tests, such as a renal ultrasound. These tests will help provide a better look at your kidneys to assess the extent of any damage.
Once kidney damage occurs, you can't reverse it. However, you can prevent further progression. This involves a combination of lifestyle changes and medications to help treat the underlying causes of stage 2 CKD.
Stage 2 kidney disease dietWhile there's no single diet available that can "cure" stage 2 CKD, focusing on the right foods and avoiding others may help increase kidney function.
Some of the worst foods for your kidneys include:
A doctor may also recommend that you cut down on both animal- and plant-based sources of protein if you're eating an excessive amount. Too much protein is hard on the kidneys.
At stage 2 CKD, you may not need to follow the some of the restrictions recommended for more advanced kidney disease, such as the avoidance of potassium.
Instead, your focus should be on maintaining a diet of fresh, whole foods from the following sources:
The following home remedies can complement a healthy diet for stage 2 CKD management:
The goal of medications for stage 2 CKD is to treat the underlying conditions that could be contributing to kidney damage.
If you have diabetes, you will need to monitor your glucose carefully.
Angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors may treat high blood pressure that's causing CKD.
Kerendia (finerenone) is a prescription medicine that can reduce the risk of sustained GFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adults with CKD associated with type 2 diabetes.
Preventing further kidney disease progression can feel like a daunting task. It's important to know that the small choices you make on a daily basis can truly impact the bigger picture of your overall kidney health. You can start by:
Occasionally, kidney disease may be found to be caused by some temporary problem, such as a side effect of a medicine or a blockage. When the cause is identified, it's possible that kidney function can improve with treatment.
There's no cure for kidney disease that has resulted in permanent damage, including mild cases diagnosed as stage 2. However, you can take action now to avoid further progression. It's possible to have stage 2 CKD and prevent it from progressing to stage 3.
People at stage 2 kidney disease are still considered to have overall healthy kidney function. Thus the prognosis is much better compared to more advanced stages of CKD.
The goal then is to prevent further progression. As CKD gets worse, it can also cause potentially life threatening complications, such as heart disease.
Stage 2 CKD is considered a mild form of kidney disease, and you may not notice any symptoms at all. Yet this can also make this stage difficult to diagnose and treat.
As a rule of thumb, you'll want to make sure you undergo regular blood and urine tests if you have any underlying conditions or a family history that increases your risk of CKD.
Once you are diagnosed with CKD, stopping the further progression of kidney damage is dependent on lifestyle changes. Talk to your doctor about how you can get started with dieting and exercising for your condition.
Study Shows Strong Association Between Atherosclerosis And Accelerated Aging
Atherosclerosis—the much-feared 'hardening' of our arteries—impacts our health long before the appearance of symptomatic cardiovascular disease. A new study by a team at the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) demonstrates a strong association between atherosclerosis at subclinical stages and an accelerated aging process.
The study is published in the European Heart Journal. Lead author and CNIC General Director Dr. Valentín Fuster emphasized that the results underline the benefits of reducing inflammation by adopting a healthy lifestyle (healthy diet, regular physical activity, etc.) or taking specific medication, such as cholesterol-lowering statins "that can block, or at least slow, the transition from the subclinical phase of atherosclerosis to the appearance of severe cerebrovascular events, like myocardial infarction or stroke."
The study shows that there is a strong association between the presence, extent, and progression of atherosclerosis at the subclinical level and accelerated epigenetic aging in otherwise healthy young individuals, said Dr. Enrique Lara Pezzi, an author on the study.
Epigenetic age is a measure of a person's biological age (the functional age of their cells and tissues) based on the idea of the epigenetic clock. Epigenetic clocks use machine learning algorithms to predict a person's biological age and life expectancy based on their level of DNA methylation, explained study first author Fátima Sánchez Cabo.
But sometimes, said Sánchez Cabo, this prediction does not correspond to a person's chronological age (the time elapsed since birth), "so that someone's epigenetic age can be older than their chronological age, whereas someone else might have an epigenetic age younger than their chronological age."
Fortunately, unlike the germinal mutations we carry in our genome, "changes in DNA methylation are reversible, opening up the possibility of 'slowing down' our epigenetic aging," assured Lara Pezzi.
The identification of an association between subclinical atherosclerosis and reduced life expectancy based on epigenetic clocks was possible thanks to a massive analysis of data from the PESA-CNIC-SANTANDER study, which is led Dr. Valentín Fuster. Since 2010, the PESA-CNIC-SANTANDER study has analyzed the progression of subclinical atherosclerosis in more than 4000 Banco Santander employees aged 40 to 54 years at the start of the study and with no prior history of cardiovascular disease.
"The follow-up of this cohort constitutes one of the most important cardiovascular prevention studies in the world," said Dr. Fuster.
The European Heart Journal study combines data on the progression of atherosclerosis obtained with advanced imaging techniques with detailed information on participants' lifestyle and data from molecular omics studies.
"These molecular data allowed us to advance our knowledge of the causal mechanisms of subclinical atherosclerosis, as well as its clinical consequences, providing key information for a more personalized treatment of the disease in its early stages," said Lara Pezzi.
Using transcriptomic and proteomic data, the study demonstrates that systemic inflammation triggered in individuals with a high burden of atherosclerotic plaques may be a key factor in accelerating their epigenetic aging.
The authors conclude that the study identifies a solid association between the presence, extent, and progression of subclinical atherosclerosis and accelerated epigenetic aging, mediated in part by low-grade chronic inflammation induced by inflammatory cytokines.
The authors nevertheless recognize that further longitudinal studies are needed over a longer follow-up period and supported by more experimental data, in order to provide a more thorough characterization of the effect of atherosclerosis on health and life expectancy and to identify underlying mechanisms.
More information: Fátima Sánchez-Cabo et al, Subclinical atherosclerosis and accelerated epigenetic age mediated by inflammation: a multi-omics study, European Heart Journal (2023). DOI: 10.1093/eurheartj/ehad361
Provided by Centro Nacional de Investigaciones Cardiovasculares Carlos III (F.S.P.)
Citation: Study shows strong association between atherosclerosis and accelerated aging (2023, June 21) retrieved 30 June 2023 from https://medicalxpress.Com/news/2023-06-strong-association-atherosclerosis-aging.Html
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Unicycive Therapeutics Provides Regulatory Update On Lanthanum Dioxycarbonate Program
Unicycive Therapeutics, Inc.
LOS ALTOS, Calif., June 29, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the "Company" or "Unicycive"), today provided an update based on recent interactions with the U.S. Food and Drug Administration (FDA or Agency) concerning the Company's New Drug Application (NDA) for lanthanum dioxycarbonate (LDC), previously known as Renazorb. LDC is an investigational new drug being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis.
In preparation for its anticipated NDA filing for LDC, the Company requested a pre-NDA meeting with the FDA to align on the contents of the NDA. As previously noted, the Agency had requested a 6-month toxicity study in mice comparing LDC and lanthanum carbonate (LC), the drug substance in Fosrenol®, the Reference Listed Drug for the 505(b)(2) regulatory pathway. The study report was submitted to the Agency as part of the pre-NDA meeting package showing that there was no evidence of any gastrointestinal (GI) neoplasms for either LC- or LDC-dosed mice. However, upon review of the study report, the Agency pointed out that although the GI adverse findings observed with LDC are qualitatively similar to lanthanum carbonate, there were quantitative differences.
Based on the review of this information, the FDA has asked the Company to provide additional information, including risk assessment and clinical data, to evaluate the tolerability of LDC in patients with chronic kidney disease on dialysis. The Company requested a follow-up meeting with the FDA to discuss its additional requests.
"We will work diligently to gain alignment with the FDA on the additional data requirements and plan to provide further updates regarding the program in the third quarter of this year," stated Shalabh Gupta, MD, CEO of Unicycive. "We remain undeterred in our enthusiasm for the potential best-in-class profile of LDC and are dedicated to bringing this important new treatment option to patients as soon as possible."
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Unicycive is seeking FDA approval of LDC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between LDC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of lanthanum dioxycarbonate to Fosrenol was established.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Lanthanum Dioxycarbonate (LDC)
Lanthanum dioxycarbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). LDC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. Dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug candidate, lanthanum dioxycarbonate (LDC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit www.Unicycive.Com.
Fosrenol® is a registered trademark of Shire International Licensing BV.1Reason Research, LLC 2022 survey. Results here.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled 'Risk Factors' in Unicycive's Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact:
ir@unicycive.Com(650) 900-5470
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