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SD standard deviation SE standard error SI International System of Units SMQ Standardised MedDRA Query SOC (MedDRA) system organ class sUA serum uricacid (also referred to as serum urate) SURI selective uricacid reabsorption inhibitor TEAE treatment-emergent adverse event UK United Kingdom ULT urate-lowering therapy URAT1 uricacid transporter 1 US United States uUA urinary uricacid vs versus XO xanthine oxidase XOI xanthine oxidase inhibitor Assessment report EMA/6459/2016 Page 5/128 1 (...) treatment of hyperuricaemia in combination with allopurinol or febuxostat in gout patients when additional therapy is warranted (i.e. not at target serum uricacid levels or with presence of tophus). Zurampic is indicated in adults. The legal basis for this application refers to: Article 8.3 of Directive 2001/83/EC - complete and independent application. The applicant indicated that lesinurad was considered to be a new active substance. The application submitted is composed of administrative information
-dihydroxyadenine calculi. The main etiologic factors for the development of uricacidnephrolithiasis are low urinary pH, hyperuricosuria, and low urinary volume. Practically, all of those who form uricacid stones have persistently low urinary pH, and most excrete normal amounts of uricacid. This suggests the potential importance of urinary pH manipulation in dissolving UA stones. Dissolution therapy for UA calculi is based on hydration and raising the urinary pH. European guidelines recommended that urine (...) and dissolution therapy Not Applicable Detailed Description: Urolithiasis is a common morbidity worldwide, affecting 10% to 15% of the population in Europe and North America. A higher prevalence of stone disease is found in hot or dry areas, including 20% to 25% in the Middle East. Radiolucent stones are mostly uricacid (UA) calculi, which varies geographically with worldwide incidence ranges from 5 to 40% and about 7- 10 percent of all calculi. Other rare radiolucent stones include xanthine and 2,8
disorders (e.g. sinu-atrial blocks of II° or III°) Myopathy Hereditary galactose or fructose intolerance, lactase deficiency, or glucose-galactose malabsorption History of nephrolithiasis Gout or clinically relevant elevation of uricacid Creatinine clearance (according to CKD EPI formula) is lower than 80 ml/min Further exclusion criteria apply Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research (...) Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Diuretics Natriuretic Agents Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers
for fluctuating liver function tests during this trial Renal impairment i.e. calculated creatinine clearance ≤60 mL/min Serum uricacid levels at Screening >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL) History or clinical diagnosis of gout Known or suspected Gilbert syndrome Indirect (unconjugated) bilirubin ≥1.2 x ULN at Screening (i.e. ≥ 1.1 mg/dL) Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer (...) and ustekinumab within 8 weeks before first randomization Use of the DHODH inhibitors leflunomide or teriflunomide within 6 months before first randomization Any use of natalizumab (Tysabri™) within 12 months before first randomization Use of the following concomitant medications is prohibited at Screening and throughout the duration of the trial: any medication known to significantly increase urinary elimination of uricacid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid
with increased level of serum magnesium. The C allele of rs1000597 was associated with higher levels of serum creatinine, uricacid, calcium and lower urine pH level. The T allele of rs4142110 was correlated with higher levels of serum magnesium, phosphorus, and lower AKP level. The G alleles of rs4293393 was associated with higher serum CO2 level. The risk alleles of these SNPs were proved to be associated with the electrolytes metabolism that may result in the formation of urolithiasis. (...) Association Study of Reported Significant Loci at 5q35.3, 7p14.3, 13q14.1 and 16p12.3 with Urolithiasis in Chinese Han Ethnicity In this study, we aimed to validate the association of 8 reported significant loci at 5q35.3, 7p14.3, 13q14.1 and 16p12.3 with urolithiasis in Chinese Han population. We performed case-control association analysis using 624 patients with nephrolithiasis and 1008 control subjects. We selected single-nucleotide polymorphism (SNPs) including rs12654812 and rs11746443
Bilateral hydronephrosis due to obstructive ureteral stone associated with norovirus gastroenteritis Recently, cases of urinary tract calculi causing hydronephrosis and postrenal renal failure associated with viral gastroenteritis were documented, yet few were related to norovirus. During norovirus gastroenteritis, observation of oliguria, aciduria, low FENa value, and elevation of blood or urinary uricacid level may necessitate clinical workout for nephrolithiasis.
abdominal film and renal sonography, a noncontrast helical computed tomography scan of the abdomen is the diagnostic procedure of choice for detection of small and radiolucent kidney stones with sensitivity and specificity of nearly 100%. Stones smaller than 5 mm in diameter often pass the urinary tract system and rarely require surgical interventions. The main risk factors for stone formation are low urine output, high urinary concentrations of calcium, oxalate, phosphate, and uricacid compounded (...) Preventive Kidney Stones: Continue Medical Education Nephrolithiasis is a common health problem across the globe with a prevalence of 15%-20%. Idiopathic hypercalciuria is the most common cause of nephrolithiasis, and calcium oxalate stones are the most common type of stones in idiopathic hypercalciuric patients. Calcium phosphate stones are frequently associated with other diseases such as renal tubular acidosis type 1, urinary tract infections, and hyperparathyroidism. Compared with flat
pressure 490 th percentile ando95 th percentile), following the age-based Recommended Daily Intake. (1C) 18.104.22.168: We recommendsupplemental freewater and sodiumsupplementsforchildrenwith CKD and polyuria to avoid chronic intravascular depletion and to promote optimal growth. (1C) Hyperuricemia 3.1.20: There is insuf?cient evidence to support or refute the use of agents to lower serum uricacid concentrations in people with CKD and either symptomatic or asymptomatic hyperuricemia in order to delay (...) antihypertensive agents; K persistent abnormalities of serum potassium; K recurrent or extensive nephrolithiasis; K hereditary kidney disease. 5.1.2: We recommend timely referral for planning renal replacement therapy (RRT) in people with progressive CKD in whom the risk of kidney failure within 1 year is 10–20% or higher w , as determined by validated risk prediction tools. (1B) *If this is a stable isolated ?nding, formal referral (i.e., formal consultation and ongoing care management) may not be necessary
of urine creatinine, electrolytes, calcium, magnesium, uricacid, citrate, oxalate, volume, and pH should be obtained. Bone Health in Children With IBD Recent data underscore the need for physicians caring for children with IBD to pay particular attention to assessing and ensuring adequate vitamin D and calcium intake by their patients. Significant deficits in bone mass have been observed in 10% to 40% of children presenting with IBD, and these deficits appear to be more pronounced in patients with CD (...) involving the small bowel, especially those with extensive disease or resections involving the terminal ileum, should have periodic assessment of serum vitamin B 12 and folate levels. Patients with CD and either significant small bowel involvement or a history of small bowel resection are also at increased risk for the development of zinc deficiency (44). Similarly, patients with CD who have undergone terminal ileal resection are at increased risk for impaired absorption of bile acids. These unabsorbed
Obstructive Uropathy as an Initial Presentation of Primary Myelofibrosis: Case Report and Review of Literature Primary myelofibrosis (PMF) is a rare hematological disorder associated with progressive cytopenia and extra-medullary hematopoiesis. Acute kidney injury in this disease has been reported from diverse etiologies such as renal and peri-renal extramedullary hematopoiesis and tumor lysis syndrome. We report a patient who presented with obstructive uropathy from uricacid stones who (...) was incidentally diagnosed with PMF during workup for persistent thrombocytosis and leukocytosis. Marrow histopathology was unique in presenting features of early PMF despite clinical picture mimicking essential thrombocythemia. Despite a common background of hyperuricemia in myeloproliferative neoplasms, AKI resulting from urate nephrolithiasis has seldom been reported in PMF. Published data on this association and clinical management is reviewed briefly.
, oxalate, potassium, magnesium, phosphate, uricacid, and urate. When an abnormality is detected on a 24-hour urine collection the assumption is that this is due to a global metabolic defect present in both kidneys. However, this may not be the case. It is possible there could be a relative imbalance with both kidneys having a defect, but to different degrees (or different defects in one or multiple electrolytes). It is also possible that one kidney has a dominant defect, but the contralateral kidney (...) in the concentrations of urine electrolytes, such as calcium. Condition or disease Intervention/treatment Kidney Calculi Nephrolithiasis Urolithiasis Procedure: Ureteral catheterization Detailed Description: Nephrolithiasis is common within the general population. Although the majority of patients with a symptomatic stone event will not require surgical intervention, the rate of recurrence is high. Therefore, reducing this rate of recurrence is important. Traditionally, this has been achieved with a combination
disorders such as bipolar disorder, schizophrenia, or major depression. Abnormal liver function (aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 × upper limit of normal (ULN), bilirubin > 1.5 ULN). Subjects with history of gout, and/or urate nephrolithiasis, and/or with abnormally low serum uricacid (below the lowest laboratory reference range both in men and women) at baseline. Other sources of pain that may confound assessment or self-evaluation of DPNP such as disseminated
and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uricacid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uricacid, cystine and computed tomography for evaluation of urinary calculus. In the second evaluation, 30 days after, anthropometric measures will be repeated, bioimpedance and nutritional assessment will be made with recommendation of daily ingestion (...) of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day and requested total serum calcium, phosphate, sodium, potassium, urea, creatinine, uricacid, and PTH, pH venous blood, urine tests type I, culture of urine and urine tests of calcium, oxalate, phosphate, sodium, potassium, citrate, magnesium, creatinine, uricacid, cystine. Patients will be monitored monthly for 3 months with anthropometric measurements, bioimpedance and strengthening of nutritional recommendations. By the end of the third
characterized. Previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests. There are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uricacid, with calcium oxalate being the most common. It is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well (...) First Posted: April 15, 2016 Last Update Posted: May 2, 2018 Last Verified: November 2016 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Keywords provided by Dirk Lange, University of British Columbia: Kidney stones Renal Calculi Additional relevant MeSH terms: Layout table for MeSH terms Kidney Calculi Nephrolithiasis Urolithiasis Kidney Diseases Urologic Diseases Urinary Calculi Calculi Pathological Conditions, Anatomical
estimated glomerular filtration rate (eGFR) and kidney size, possibly indicating greater kidney functional reserve. Greater uromodulin excretion is associated with markers of volume overload such as fractional excretion of uricacid, sodium and chloride, indicating a possible role in salt and water retention. Recent evidence also suggests that higher uromodulin levels are associated with lower risk of eGFR decline, death and possibly a lower risk of acute kidney injury. Higher levels of uromodulin (...) Uromodulin in kidney health and disease. Although uromodulin or Tamm-Horsfall protein was discovered over 60 years ago, its functional role in humans remains unclear. This review highlights new studies elucidating the clinical correlates of uromodulin, its association with kidney function decline, nephrolithiasis and urinary host defense.Uromodulin is evolutionarily conserved and has multiple functional roles. In large population studies, higher levels of uromodulin are associated with higher
A Novel Homozygous SLC2A9 Mutation Associated with Renal-Induced Hypouricemia. Hereditary renal hypouricemia (RHUC) is a genetically heterogenous disorder characterized by defective uricacid (UA) reabsorption resulting in hypouricemia and increased fractional excretion of UA; acute kidney injury (AKI) and nephrolithiasis are recognized complications. Type 1 (RHUC1) is caused by mutations in the SLC22A12 gene, whereas RHUC2 is caused by mutations in the SLC2A9 gene. Patient ethnicity is diverse
Criteria: Known uricacid, cystine, or struvite stone disease Hypercalcemia (serum calcium >10.4 mg/dl within the past 12 months) Gross hematuria within the past 6 months Acute stone event within the past 1 month Recent stone intervention within the past 1 month Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer) Addition or dose change of medicines potentially affecting urinary calcium (...) followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU