A Prospective, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Using an Orally Administered Oxalate Decarboxylase (OxDC)
| Autor: | Gary Stevens, Sabrina Buzzerd, Howard Liu, Alan S. Ryan, Victoria Bird, Ira W. Klimberg, Emily Quintero |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Carboxy-Lyases Urinary system 030232 urology & nephrology Calcium oxalate Original Investigations Renal function Placebo Gastroenterology Oxalate Oxalate decarboxylase Kidney Calculi 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine medicine Humans Prospective Studies Cross-Over Studies business.industry General Medicine medicine.disease Crossover study chemistry 030220 oncology & carcinogenesis Kidney stones business |
| Zdroj: | Kidney360 |
| ISSN: | 2641-7650 |
| Popis: | BACKGROUND: 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. METHODS: 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 (750–800 mg oxalate, 500–550 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. RESULTS: 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% (P5% reduction) in 31 of 33 subjects (94%). Compared with placebo, OxDC produced a 24% reduction (P |
| Databáze: | OpenAIRE |
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