, 52% of those who received ferric citrate saw their hemoglobin levels rise by at least 1g/dl of blood during the trial. That compared with 19% in the placebo group who experienced a 1g/dl increase. The initial results for the oral, iron-based drug were both statistically significant and clinically meaningful, the company said [14].
30/03/2016 09:18:39
Jul 14: PIII PERFECTED study (PhosphatE binding and iRon delivery with FErric CiTrate in EsrD) published in the Journal of the American Society of Nephrology. The results showed Zerenex demonstrated a statistically significant treatment difference versus the active control group in mean change in serum ferritin (+306 ng/mL vs. +19 ng/mL) and TSAT (+8% vs -1.2%) from baseline (day 0) to week 52. In the PERFECTED study, subjects randomized to receive Zerenex required significantly lower dosages of IV iron and ESA; and hemoglobin levels were higher in Zerenex treated patients than in those receiving active control [9].
29/07/2014 09:27:58
Jan 13: Results from a PIII long-term study in 441 ESRD patients on hemodialysis or peritoneal dialysis reported, randomised 2:1 to receive either Zerenex or an active control (sevelamer carbonate &/or calcium acetate) for 52 wks. Subjects randomised to treatment with Zerenex were the randomised in a 1:1 ratio to either continue treatment with Zerenex or switch to placebo for a 4-week treatment period. Subjects were titrated during the study to achieve serum phosphorus levels that ranged between 3.5 to 5.5 mg/dL. Zerenex met the primary efficacy endpoint (mean change in serum phosphorus from baseline (Week 52) to end of the four-week Efficacy Assessment Period (Week 56) in the ITT group (n=183) 1.9 vs. -0.3 (Least Squares (LS) Mean Difference from Placebo -2.3; p<0.0001) [4].
30/01/2013 13:48:07
Sep 11: Completed enrolment of long-term study component of Phase III study for the treatment of elevated serum phosphorus levels (hyperphosphataemia) in patients with end-stage renal disease (ESRD) on dialysis. The study consists of a two-week washout period followed by a 52-week safety assessment in which patients are randomised (2:1) to receive either Zerenex or an active control, followed by a four-week efficacy assessment [3].
23/04/2012 15:24:45
May 11: Results of PIII study in 146 dialysis patients presented. The study met the primary endpoint (to determine whether there was a dose response in the change in serum phosphorus from Baseline to Day 28) with analysis indicating a highly statistically significant dose response (p<0.0001). Also noted was statistically significant dose response increase in serum bicarbonate suggesting potential to address metabolic acidosis, significant dose response reduction in calcium x phosphorus product, modest upward trends in Ferritin and TSAT in 6 grams/day and 8 grams/day dose groups supports theory that Zerenex could reduce the need for intravenous iron and erythropoiesis-stimulating agent (ESA) use [2].
23/04/2012 15:23:52
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003776/WC500194873.pdf
References
Available only to registered users
Category
BNF Category: Phosphate-binding agents (09.05.02.02)
Pharmacology: An orally available phosphate binder
Epidemiology: Preva lence of CKD 4/5 is 1% or less in England (520,000 people). Nearly 26,000 are rec |
