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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data?.

ABSTRACT: Ferric citrate is an approved phosphate binder for use in patients with chronic kidney disease on dialysis. Clinical trials demonstrated that ferric citrate controlled serum phosphorus levels and increased iron stores. The aim of this retrospective chart review was to evaluate real-world bone mineral and anemia parameter data from patients treated with ferric citrate. 92 adult dialysis patients taking ferric citrate (average starting dose of 6 tablets/day) for at least 6 months were included. Bone mineral, anemia, and iron biomarker levels were extracted from patient medical records before and during the first 6 months of ferric citrate treatment; 21 (23%) patients were phosphate binder naïve, and 71 (77%) patients had been on other phosphate binders. Before starting ferric citrate, 22% of patients had serum phosphorus ? 5.5 mg/dL, increasing to 65% of patients at 6 months of treatment (month 6). Mean (standard error of the mean (SEM)) baseline serum phosphorus was 6.55 ± 0.17 mg/dL decreasing to 5.40 ± 0.17 mg/dL at month 6. Mean (SEM) baseline hemoglobin, ferritin, and transferrin saturation were 10.6 ± 0.2 g/dL, 734 ± 65 ng/mL, and 27.1 ± 1.6%, respectively, and 11.1 ± 0.2 g/dL, 947 ± 66 ng/mL, and 37 ± 1.9%, respectively, at month 6. The serum phosphorus and anemia biomarker levels observed in this retrospective chart review were similar to those seen in clinical trials.?.

SUBMITTER: Hain DJ

PROVIDER: S-EPMC5467155 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data .

Hain Debra J DJ Marinaro Meredith M Koeper David W DW Rosenthal Melissa A MA Chillemi Salvatore S Huffman Jennifer M JM Gerbeling Teresa T Pritsiolas James M JM Loram Lisa C LC Pergola Pablo E PE

Clinical nephrology 20170701 1

Ferric citrate is an approved phosphate binder for use in patients with chronic kidney disease on dialysis. Clinical trials demonstrated that ferric citrate controlled serum phosphorus levels and increased iron stores. The aim of this retrospective chart review was to evaluate real-world bone mineral and anemia parameter data from patients treated with ferric citrate. 92 adult dialysis patients taking ferric citrate (average starting dose of 6 tablets/day) for at least 6 months were included. Bo ...[more]

PMID: 28561732

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Project description:BackgroundPatients with end-stage renal disease (ESRD) require phosphate binders for hyperphosphatemia and erythropoiesis-stimulating agents (ESAs) and intravenous (i.v.) iron for anemia. Ferric citrate (FC) is a novel, iron-based phosphate binder that increases iron stores and decreases i.v. iron and ESA usage while maintaining hemoglobin levels, and may decrease the cost of ESRD care. The study objectives were to (1) quantify differences in ESA and i.v. iron usage among ESRD patients receiving FC compared with active control (AC) (sevelamer carbonate and/or calcium acetate) on the basis of data from a 52-week phase III clinical trial and (2) standardize trial data to the general United States (US) ESRD population and calculate the potential impact of FC on ESRD cost/patient/year in the USA.Study designThe study was a randomized, controlled clinical trial.Setting and populationA total of 441 adult subjects with ESRD who received FC or AC for 52 weeks were included.Model, perspective, and timelineDifferences in ESA and i.v. iron usage between the treatment groups were modeled over time using generalized linear mixed models and zero-inflated Poisson models. Trends were modeled via logarithmic curves, and utilization patterns were applied to the general dialysis population to estimate expected resource savings.OutcomesStudy outcomes were costs saved/patient/year using FC versus AC (US dollars).ResultsOur model suggests an annual decrease of 129,106 U of ESAs and 1960 mg of i.v. iron per patient in the second year after a switch from AC to FC. Applying 2013 Medicare pricing, this would save $1585 in ESAs and $516 in i.v. iron: a total of $2101/patient/year; these savings would be expected to double for managed care plans.LimitationsThe projections were made on 1 year of trial data.ConclusionsPhosphate binding with FC reduces i.v. iron and ESA usage. Given the high cost burden of ESRD, our model demonstrates significant potential cost savings.Trial registrationClinicalTrials.gov (NCT01191255) http://clinicaltrials.gov/ct2/show/NCT01191255 .

Project description:BackgroundSerum phosphorus (SP) level is closely associated with overall mortality and cardiovascular events, while the role of SP controlled duration is not fully recognized. Here, we conducted a retrospective cohort study in our department to identify the relationship of SP controlled duration with clinical outcomes in patients undergoing peritoneal dialysis (PD).MethodsPD patients in our center from January 1, 2009, to June 30, 2019, were followed up at 2-month (the first year) or 5-month (the next follow-up period) intervals, and until death, until PD withdrawal, or until June 30, 2019. Data at each follow-up point were collected from their medical records. SP levels, changed degree of SP over baseline, and SP controlled duration were analyzed with overall mortality, PD withdrawal (including death, transferred to hemodialysis, and received renal transplantation), and combined endpoint (including death, acute heart failure, cardiovascular event, and stroke).ResultsA total of 530 patients entered the analysis. Of them, 456 (86.0%) had hyperphosphatemia before dialysis, and the SP levels decreased soon after dialysis. The degree of SP change over baseline was the maximum at the 3rd month after dialysis (-31.0%), and lower degree was associated with higher overall mortality (hazard ratio [HR], 1.012; 95% CI, 1.004-1.020; p = 0.003). The median SP controlled duration was 13 (5-28) months, and longer duration was significantly associated with lower overall mortality (HR, 0.968; 95% CI, 0.956-0.981; p < 0.001). After categorization, duration more than 12 months greatly improved overall mortality with a HR of 0.197 (0.082-0.458; p < 0.001 vs. SP never controlled group) and 0.329 (0.150-0.724; p = 0.006 vs. duration <12 months group). Longer SP controlled duration also improved PD withdrawal and combined endpoint.ConclusionsIn summary, both degree and duration of SP control were tightly associated with overall mortality. We should control SP levels as early, as possible, and as long as we could.

Project description:BackgroundElevated serum phosphorus (P) levels have been linked to increased morbidity and mortality in dialysis patients with secondary hyperparathyroidism (SHPT) but may be difficult to control if parathyroid hormone (PTH) is persistently elevated. We conducted a post hoc analysis of data from an earlier interventional study (OPTIMA) to explore the relationship between PTH control and serum P.MethodsThe OPTIMA study randomized dialysis patients with intact PTH (iPTH) 300-799 pg/mL to receive conventional care alone (vitamin D and/or phosphate binders [PB]; n=184) or a cinacalcet-based regimen (n=368). For patients randomized to conventional care, investigators were allowed flexibility in using a non-cinacalcet regimen (with no specific criteria for vitamin D analogue dosage) to attain KDOQI™ targets for iPTH, P, Ca and Ca x P. For those assigned to the cinacalcet-based regimen, dosages of cinacalcet, vitamin D sterols, and PB were optimized over the first 16 weeks of the study, using a predefined treatment algorithm. The present analysis examined achievement of serum P targets (≤ 4.5 and ≤ 5.5 mg/dL) in relation to achievement of iPTH ≤ 300 pg/mL during the efficacy assessment phase (EAP; weeks 17-23).ResultsPatients who achieved iPTH ≤ 300 pg/mL (or a reduction of ≥ 30% from baseline) were more likely to achieve serum P targets than those who did not, regardless of treatment group. Of those who did achieve iPTH ≤ 300 pg/mL, 43% achieved P ≤ 4.5 mg/dL and 70% achieved P ≤ 5.5 mg/dL, versus 21% and 46% of those who did not achieve iPTH ≤ 300 pg/mL. Doses of PB tended to be higher in patients not achieving serum P targets. Patients receiving cinacalcet were more likely to achieve iPTH ≤ 300 pg/mL than those receiving conventional care (73% vs 23% of patients). Logistic regression analysis identified lower baseline P, no PB use at baseline and cinacalcet treatment to be predictors of achieving P ≤ 4.5 mg/dL during EAP in patients above this threshold at baseline.ConclusionsThis post hoc analysis found that control of serum P in dialysis patients was better when serum PTH levels were lowered effectively, regardless of treatment received.Trial registrationClinicaltrials.gov identifier NCT00110890.

Project description:Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels.52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment.Maintenance dialysis patients with serum phosphorus levels ?6.0 mg/dL after washout of prior phosphate binders.2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate).Changes in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year.Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate.There were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (-2.04±1.99 [SD] vs -2.18±2.25 mg/dL, respectively; P=0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22±0.90 vs 0.31±0.95 mg/dL; P=0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (-167.1±399.8 vs -152.7±392.1 pg/mL; P=0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control.Open-label study, few peritoneal dialysis patients.Ferric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate.

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data?.

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data .

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data?.

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data .

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OmicsDI is part of the ELIXIR infrastructure

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Ferric citrate controls serum phosphorus in dialysis patients: retrospective data .