Background. Primary goal of this randomized, double-blind, placebo-controlled crossover study of Renadyl in end-stage renal\ndisease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in\nlevels of known uremic toxins. Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative\nstress. Methods. Two 2-month treatment periods separated by 2-month washout and crossover, with physical examinations, venous\nblood testing, and quality of life questionnaires completed at each visit. Datawere analyzed with SAS V9.2. Results. 22 subjects (79%)\ncompleted the study. Observed trends were as follows (none reaching statistical significance): decline inWBC count (?0.51Ã?â??109/L,\nP = 0.057) and reductions in levels of C-reactive protein (?8.61mg/L, P = 0.071) and total indoxyl glucuronide (?0.11mg%, P =\n0.058). No statistically significant changes were observed in other uremic toxin levels or measures of QOL. Conclusions. Renadyl\nappeared to be safe to administer to ESRD patients on hemodialysis. Stability in QOL assessment is an encouraging result for a\npatient cohort in such advanced stage of kidney disease. Efficacy could not be confirmed definitively, primarily due to small sample\nsize and low statistical powerââ?¬â?further studies are warranted.
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