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Uric Acid Nephrolithiasis

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101. Topiloric/Uriadec (topiroxostat)

for the indications and dosage and administration as shown below. [Indication] Gout, hyperuricaemia [Dosage and administration] The usual adult initial dosage is 20 mg/dose of topiroxostat orally administered twice daily in the morning and evening. Thereafter, the dose should be gradually increased, as needed, while monitoring blood uric acid levels. The usual maintenance dosage should be 60 mg/dose twice daily. The dose may be adjusted according to the patient’s condition, up to 80 mg/dose twice daily. 4 Review (...) of topiroxostat orally administered twice daily in the morning and evening. Thereafter, the dosage should be gradually increased, as needed, while monitoring blood uric acid levels. The usual maintenance dosage should be 60 mg/dose twice daily. The dose may be adjusted according to the patient’s condition, up to 80 mg/dose twice daily. II. Summary of the Submitted Data and Outline of Review by the Pharmaceuticals and Medical Devices Agency (PMDA) A summary of the submitted data and an outline of the review

2013 Pharmaceuticals and Medical Devices Agency, Japan

102. Modification of lifestyle and nutrition interventions for management of early chronic kidney disease

, diuresis, natriuresis, and kaliuresis with associated blood pressure changes, increased risk for nephrolithiasis, and various metabolic alterations. Although there was a dearth of evidence pertaining to HP diets in patients with CKD, it was concluded that, while there are no clear renal-related contraindications to HP diets in individuals with healthy kidney function, the theoretical risks should (...) therapy. Once blood pressure is controlled, low-dose acetylsalicylic acid therapy should be considered. _______________________________________________________________________________________________________________________ Early Chronic Kidney Disease July 2012 Page 20 of 50 SUGGESTIONS FOR FUTURE RESEARCH 1. An RCT of different levels of fluid intake ( 3L/day) on CKD progression in patients with stage 1-3 CKD. 2. A study of the impact of moderation of alcohol intake on CKD progression in patients

2013 KHA-CARI Guidelines

106. Teriflunomide

baseline Analyte Placebo Ter 7 Ter 14 Uric acid (range 125-428 umol/L) -3.8 -58.3 -77.8 CK (0-190 U/L) (measured only in 2001) -2.89 -2.62 +10.77 LDH (range 0-479 U/L) (measured only in 2001) -0.43 +17.89 +15.98 ALT (range 6-34 U/L) 0.009 0.112 0.095 WBC (range 3.8-10.7 GIGA/L) 0.01 -0.67 -0.85 Neutrophils (range 1.96-7.23 GIGA/L) 0.00 -0.47 -0.59 Lymphocytes (range 0.91-4.28 GIGA/L) 0.00 -0.22 -0.28 Hemoglobin (range 116-164 G/L) -1.3 -1.9 -2.4 Platelets (range 140-400 GIGA/L) 8.2 -14.1 -14.7 (...) In general, these changes tend to occur early (within the first 6-12 weeks) and then remain stable. Reference ID: 3185084 19 Outliers The following chart displays the percent of patients who met criteria for potentially clinically important changes for the various laboratory analytes: Analyte Placebo Ter 7 Ter 14 Phosphorus >0.6 and 0.3 and 7 mmol/L 0.2% 1% 1% Creatinine >150 umol/L 0% 1% 1% > 2 X baseline 0% 1% 1% > 3 x Baseline 0% 1% 1% Uric acid 3 - 2.5 - 0.5 5% 10% 4.5% Lymphocytes 0.5 Giga/L 5% 7

2012 FDA - Drug Approval Package

108. Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy

Last Update Posted : September 14, 2018 See Sponsor: Assiut University Information provided by (Responsible Party): radwa awad abd elhafiz ibrahim, Assiut University Study Details Study Description Go to Brief Summary: diabetic nephropathy is one of the leading causes of end stage renal disease Condition or disease Intervention/treatment Phase Diabetic Nephropathy Diagnostic Test: renal arterial resistive index Diagnostic Test: uric acid level Diagnostic Test: serum urea and creatinine Diagnostic (...) Study Completion Date : September 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: cases laboratory tests including (random blood glucose , serum urea and creatinine , lipogram , serum uric acid , HbA1c , urine analysis , 24 hours urinary proteins ) abdominal ultrasonography dupplex on the renal vessels Diagnostic Test: renal arterial resistive index done by dupplex on renal arteries Diagnostic

2018 Clinical Trials

109. Abdominal Radiography with Digital Tomosynthesis: an Alternative to Computed Tomography for Identification of Urinary Calculi? (Abstract)

was determined using nearest-neighbor match with generalized linear mixed modeling.Total of 59 stones were identified on reference read. Overall, NCCT and DT were both superior to KUB alone (P < .001) while the difference between DT and NCCT was not significant (P = .06). When evaluating uric acid stones, NCCT and DT outperformed KUB (P < .01 and P < .05, respectively) while DT and NCCT were similar (P = .16). Intrarenal stones were better evaluated on DT and NCCT (P < .001 compared to KUB), while DT (...) Abdominal Radiography with Digital Tomosynthesis: an Alternative to Computed Tomography for Identification of Urinary Calculi? To compare the accuracy of plain abdominal radiography (kidneys, ureter, and bladder [KUB]) with digital tomosynthesis (DT) to noncontrast computed tomography (NCCT), the gold standard imaging modality for urinary stones. Due to radiation and cost concerns, KUB is often used for diagnosis and follow-up of nephrolithiasis. DT, a novel technique that produces high-quality

2018 Urology

110. A heterozygous variant in the SLC22A12 gene in a Sri Lanka family associated with mild renal hypouricemia. Full Text available with Trip Pro

A heterozygous variant in the SLC22A12 gene in a Sri Lanka family associated with mild renal hypouricemia. Renal hypouricemia is a rare heterogeneous inherited disorder characterized by impaired tubular uric acid transport, reabsorption insufficiency and /or acceleration of secretion. The affected individuals are predisposed to nephrolithiasis and recurrent episodes of exercise-induced acute kidney injury. Type 1 is caused by dysfunctional variants in the SLC22A12 gene (URAT1), while type 2 (...) is caused by defects in the SLC2A9 gene (GLUT9). To date, more than 150 patients with the loss-of-function mutations for the SLC22A12 gene have been found (compound heterozygotes and/or homozygotes), most of whom are Japanese and Koreans.Herein, we report a nine year old Sri Lankan boy with renal hypouricemia (serum uric acid 97 μmol/L, fractional excretion of uric acid 33%).The sequencing analysis of SLC22A12 revealed a potentially deleterious missense variant c.1400C > T (p.T467 M, rs200104135

2018 BMC Pediatrics

111. Diagnosis and management of glycogen storage disease type I: a practice guideline of the American College of Medical Genetics and Genomics

to hyperfiltration may occur in adolescents and young adults with GSD I, similar to what is seen in diabetic patients. Severe renal injury with proteinuria, hypertension, and decreased creatinine clearance due to focal segmental glomeru- losclerosis and interstitial fibrosis, ultimately leading to end- stage renal disease, may also be seen in young adults. 62 Patients with persistently elevated blood lactate, serum lipids, and uric acid levels appear more at risk for nephropathy. 58,63 Patients with GSD Ib have (...) , a hyperlipidemia Hypoglycemia is usually less severe, but the patient may have more severe ketosis and absence of hyperlactatemia and hyperuricemia; ? AST , ALT usually higher (may be >500? U/l); cardiac and skeletal muscle involvement with ? CK concentrations in GSD IIIa; normal blood lactate and uric acid GSD IV (branching enzyme deficiency) Hepatomegaly, ? AST and ALT, a prolonged PT and low albumin in advanced stage of disease Lack of hypoglycemia until end-stage liver disease; PT commonly prolonged in GSD

2014 American College of Medical Genetics and Genomics

112. Medical Management of Kidney Stones

. (Clinical Principle) 4. Clinicians should obtain or review available imaging studies to quantify stone burden. (Clinical Principle) 5. Clinicians should perform additional metabolic testing in high-risk or interested first-time stone formers and recurrent stone formers. (Standard; Evidence Strength: Grade B) 6. Metabolic testing should consist of one or two 24-hour urine collections obtained on a random diet and analyzed at minimum for total volume, pH, calcium, oxalate, uric acid, citrate, sodium (...) . Clinicians should counsel patients with uric acid stones or calcium stones and relatively high urinary uric acid to limit intake of non-dairy animal protein. (Expert Opinion) 13. Clinicians should counsel patients with cystine stones to limit sodium and protein intake. (Expert Opinion) Pharmacologic Therapies 14. Clinicians should offer thiazide diuretics to patients with high or relatively high urine calcium and recurrent calcium stones. (Standard; Evidence Strength Grade B) 15. Clinicians should offer

2014 American Urological Association

113. Chronic Kidney Disease for the Medical Resident: A Cheat Sheet for Primary Care Providers

electrolytes for eGFR and electrolyte abnormalities (e.g. metabolic acidosis) ● Complete Blood Cell Count (Anemia) ● Lipid profile ● Uric Acid ● Serum albumin ● Renal ultrasound ○ to look for hydronephrosis, obstruction, cysts, stones, and assess kidney size and characterization ● Urinalysis ○ Quantify proteinuria with urine protein-to-creatinine ratio (Urine albumin-to-creatinine will miss multiple myeloma Bence-Jones proteins) ○ Look for hematuria or other signs of glomerulonephritis ● Consider biopsy (...) to the glomerular filtering capabilities. Other risk factors include a family history of CKD, autoimmune disease (e.g. SLE, vasculitis, scleroderma), HIV, Hepatitis B or C, amyloidosis, obstructive nephropathy from recurrent UTI or nephrolithiasis, and certain medications ( , immune suppressants, HIV medications). may also contribute to CKD, . Recent evidence suggests . Staging and Estimating GFR Staging CKD is most frequently done by calculating the estimated glomerular function rate (eGFR) as a proxy

2018 Renal Fellow Network

114. Health Supervision in the Management of Children and Adolescents With IBD: NASPGHAN Recommendations

of urine creatinine, electrolytes, calcium, magnesium, uric acid, 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

2012 North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition

115. 2012 KDIGO Clinical Practice Guideline for the Evaluation and Management of CKD

pressure 490 th percentile ando95 th percentile), following the age-based Recommended Daily Intake. (1C) 3.1.19.2: 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 uric acid 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

2012 National Kidney Foundation

117. (SWL) Versus (ODT) Versus Combined SWL And ODT For Radiolucent Stone

-dihydroxyadenine calculi. The main etiologic factors for the development of uric acid nephrolithiasis are low urinary pH, hyperuricosuria, and low urinary volume. Practically, all of those who form uric acid stones have persistently low urinary pH, and most excrete normal amounts of uric acid. 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 uric acid (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

2017 Clinical Trials

118. This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men

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 uric acid 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

2017 Clinical Trials

119. Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

for fluctuating liver function tests during this trial Renal impairment i.e. calculated creatinine clearance ≤60 mL/min Serum uric acid 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 uric acid, in particular lesinurad (Zurampic™) as well as uricosuric drugs such as probenecid

2017 Clinical Trials

120. Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

, others) Chronic indwelling catheters or stents Ileal loops or vesico-urethral reflux Recent trauma to the pelvis or urinary tract within the prior 30 days History of seizures Patients with a history of blood dyscrasias Patients with a history of uric acid kidney stones Patients with acute gouty attack Patients on chronic methotrexate therapy Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy test result within 24 hours of study (...) of an indwelling catheter ii. >100 mL of residual urine after voiding iii. Neurogenic bladder iv. Obstructive uropathy due to nephrolithiasis, tumor or fibrosis v. Azotemia due to intrinsic renal disease vi. Urinary retention in men possibly due to benign prostatic hypertrophy vii. Surgically modified or abnormal urinary tract anatomy At least two of the following signs or symptoms: Rigors, chills or fever/hypothermia Flank pain or pelvic pain Nausea or vomiting Dysuria, urinary frequency or urinary urgency

2017 Clinical Trials

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