{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T20:30:01Z","timestamp":1786480201711,"version":"build-2736575974"},"reference-count":19,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"11","funder":[{"name":"Oxidien Pharmaceuticals, LLC"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Kidney360"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hyperoxaluria is typically associated with excessive oxalate intake in the diet, decreased dietary calcium, hyperabsorption of oxalate, or increased endogenous production of oxalate. The disorder spectrum extends from recurrent kidney stones to ESKD. This clinical trial sought to evaluate the effectiveness of an acid stable oxalate decarboxylase (OxDC) to reduce urinary oxalate in healthy subjects on a high-oxalate diet.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this prospective, double-blind, randomized, placebo-controlled, crossover clinical trial, 33 healthy volunteers were randomized into two crossover sequences separated by a 2-day washout period. A controlled high-oxalate diet (750\u2013800 mg oxalate, 500\u2013550 mg calcium daily) was utilized, and six 24-hour urine collections were measured. Subjects were given approximately 1000 U (micromoles per minute per milligram) of OxDC or placebo with meals three times daily during the 4 days of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Urinary oxalate significantly decreased with OxDC treatment. The baseline corrected within-subject mean reduction in 24-hour urinary excretion (after OxDC dosing versus high-oxalate baseline preceding treatment) was 12.5 mg or 29% (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). OxDC treatment was effective (&gt;5% reduction) in 31 of 33 subjects (94%). Compared with placebo, OxDC produced a 24% reduction (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001) in 24-hour oxalate excretion. Other urinary parameters (creatinine, uric acid, citrate, magnesium, calcium) were not affected by OxDC. No serious adverse events and no product-related adverse events occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>An orally administered OxDC is capable of significantly reducing urinary oxalate levels in healthy volunteers on a high-oxalate diet without affecting creatinine clearance, urine creatinine, or other solutes related to supersaturation of calcium oxalate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>Evaluation of Nephure, and the Reduction of Dietary Oxalate, in Healthy Volunteers, NCT03661216<\/jats:p>\n                  <\/jats:sec>","DOI":"10.34067\/kid.0001522020","type":"journal-article","created":{"date-parts":[[2020,9,3]],"date-time":"2020-09-03T21:50:23Z","timestamp":1599169823000},"page":"1284-1290","source":"Crossref","is-referenced-by-count":17,"title":["A Prospective, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Using an Orally Administered Oxalate Decarboxylase (OxDC)"],"prefix":"10.34067","volume":"1","clinical-trial-number":[{"clinical-trial-number":"nct03661216","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03661216","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Emily","family":"Quintero","sequence":"first","affiliation":[{"name":"University of Florida College of Medicine, Gainesville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria Yvonne","family":"Bird","sequence":"additional","affiliation":[{"name":"National Medical Association and Research Group, Gainesville, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Howard","family":"Liu","sequence":"additional","affiliation":[{"name":"QPS-Qualitix, Springfield, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Stevens","sequence":"additional","affiliation":[{"name":"Dynastat Consulting, Inc., Bastrop, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan S.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Clinical Research Consulting, Boynton Beach, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina","family":"Buzzerd","sequence":"additional","affiliation":[{"name":"Dynamic Clinical Research LLC, High Springs, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ira W.","family":"Klimberg","sequence":"additional","affiliation":[{"name":"Florida Medical Management LLC, Ocala, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2020,11,25]]},"reference":[{"key":"B1-20230821","doi-asserted-by":"crossref","first-page":"435","DOI":"10.1517\/14656566.2013.775250","article-title":"Kidney stones: An update on current pharmacological management and future directions","volume":"14","author":"Xu","year":"2013","journal-title":"Expert Opin Pharmacother"},{"key":"B2-20230821","doi-asserted-by":"crossref","first-page":"1037","DOI":"10.1046\/j.1523-1755.2003.00807.x","article-title":"Dietary risk factors for hyperoxaluria in calcium oxalate stone formers","volume":"63","author":"Siener","year":"2003","journal-title":"Kidney Int"},{"key":"B3-20230821","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1016\/j.juro.2014.05.006","article-title":"Medical management of kidney stones: AUA guideline","volume":"192","author":"Pearle","year":"2014","journal-title":"J Urol"},{"key":"B4-20230821","doi-asserted-by":"crossref","first-page":"241","DOI":"10.1016\/j.yrtph.2017.03.016","article-title":"In vitro and in vivo safety evaluation of NephureTM","volume":"86","author":"Cowley","year":"2017","journal-title":"Regul Toxicol Pharmacol"},{"key":"B5-20230821","doi-asserted-by":"crossref","first-page":"235","DOI":"10.5527\/wjn.v4.i2.235","article-title":"Primary and secondary hyperoxaluria: Understanding the enigma","volume":"4","author":"Bhasin","year":"2015","journal-title":"World J Nephrol"},{"key":"B6-20230821","doi-asserted-by":"crossref","first-page":"e437","DOI":"10.2741\/1135","article-title":"Diagnostic and therapeutic approaches in patients with secondary hyperoxaluria","volume":"8","author":"Hoppe","year":"2003","journal-title":"Front Biosci"},{"key":"B7-20230821","doi-asserted-by":"crossref","first-page":"1401","DOI":"10.1016\/S0022-5347(17)36400-5","article-title":"The stomach: A new and powerful oxalate absorption site in man","volume":"149","author":"Hautmann","year":"1993","journal-title":"J Urol"},{"key":"B8-20230821","doi-asserted-by":"crossref","first-page":"114","DOI":"10.7326\/0003-4819-106-1-114","article-title":"Implementation of SI units for clinical laboratory data. 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