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Ketteler M.,Klinikum Coburg | Martin K.J.,Saint Louis University | Wolf M.,University of Miami | Amdahl M.,Abbott Laboratories | And 5 more authors.
Nephrology Dialysis Transplantation | Year: 2012

Background. Optimal treatment for secondary hyperparathyroidism (SHPT) has not been defined. The IMPACT SHPT (ClinicalTrials.gov identifier: NCT00977080) study assessed whether dose-titrated paricalcitol plus supplemental cinacalcet only for hypercalcaemia is superior to cinacalcet plus low-dose vitamin D in controlling intact parathyroid hormone (iPTH) levels in patients with SHPT on haemodialysis. Methods. In this 28-week, multicentre, open-label Phase 4 study, participants were randomly selected to receive paricalcitol or cinacalcet plus low-dose vitamin D. Randomization and analyses were stratified by mode of paricalcitol administration [intravenous (IV) or oral]. The primary efficacy end point was the proportion of subjects who achieved a mean iPTH value of 150300 pg/mL during Weeks 2128. Results. Of 272 subjects randomized, 268 received one or more dose of study drug; 101 in the IV and 110 in the oral stratum with two or more values during Weeks 2128 were included in the primary analysis. In the IV stratum, 57.7 of subjects in the paricalcitol versus 32.7 in the cinacalcet group (P 0.016) achieved the primary end point. In the oral stratum, the corresponding proportions of subjects were 54.4 for paricalcitol and 43.4 for cinacalcet (P 0.260). CochranMantelHaenszel analysis, controlling for stratum, revealed overall superiority of paricalcitol (56.0) over cinacalcet (38.2; P 0.010) in achieving iPTH 150300 pg/mL during Weeks 2128. Hypercalcaemia occurred in 4 (7.7) and 0 (0) of paricalcitol-treated subjects in the IV and oral strata, respectively. Hypocalcaemia occurred in 46.9 and 54.7 of cinacalcet-treated subjects in the IV and oral strata, respectively. Conclusion. Paricalcitol versus cinacalcet plus low-dose vitamin D provided superior control of iPTH, with low incidence of hypercalcaemia. © The Author 2012. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.2012This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc/3.0), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. © © The Author 2012. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Larkin J.,Pacific Renal Research Institute
Nephrology news & issues | Year: 2012

Vitamin D deficiency is a common health complication in patients with chronic kidney disease and can be treated with an abundance of classical and advanced pharmaceutics. However, the impact of bundling in dialysis clinics limits the use of the most optimal therapeutics and desired efficacy targets in end-stage renal disease patients. To address this issue, we investigated the benefits of adding a cost-effective antioxidant and vitamin D nutraceutical (MV-ONE, Nephrian Inc.) to patient regiments. This nutraceutical was used in an attempt to replete vitamin D levels and decrease inflammation that dialysis patients experience. Additionally, we investigated the potential of this therapy to reduce the need for erythropoietin-stimulating agents. Results indicate MV-ONE caused: (1) increases in 25-OH vitamin D (p = 0.0058), (2) decreases in ESA dose (p = 0.0475), and (3) no change in C-reactive protein (p = 0.3290). Overall, this suggests the addition of MV-ONE does benefit the vitamin D deficiency and anemia observed in ESRD patients.

Schiller B.,Satellite Healthcare | Bhat P.,College of the Atlantic | Sharma A.,Pacific Renal Research Institute
Clinical Therapeutics | Year: 2014

Background Intravenous (IV) iron is the treatment of choice for iron-deficiency anemia (IDA) in patients with dialysis-dependent chronic kidney disease (DD-CKD). However, IV iron products have been associated with serious adverse events (SAEs), including anaphylactoid reactions. Ferumoxytol is an IV iron preparation that can be injected over a short period of time. Although randomized clinical trials support ferumoxytol's efficacy and safety, additional insights may be drawn from the acquisition of long-term, repeat dosing efficacy and safety data in a real-world setting. Objective The goal of this study was to characterize the effectiveness and safety profile of ferumoxytol as administered to adult DD-CKD patients with IDA in a real-world setting. The ability of ferumoxytol to maintain hemoglobin (Hb), transferrin saturation (TSAT), and ferritin treatment targets established by the 2006 Kidney Disease Outcomes Quality Initiative guidelines was determined in 3 medium-sized US-based dialysis chains. Methods This retrospective, observational study was conducted to examine laboratory and dosing data for all patients who received any dose of ferumoxytol at 3 US-based dialysis chains over a 12-month period. Investigators and/or physicians from each of the chains also made independent determinations regarding the seriousness of any adverse event (AE). Special attention was paid to the incidence and types of AEs and SAEs that were potentially associated with ferumoxytol. Results Over the 12-month observation period, 8666 patients (mean [SD] age in chains A, B and C, 63.9 [14.8], 63.9 [14.9] and 63.6 [15.1], respectively), were treated with 33,358 doses of ferumoxytol across the 3 chains. Treatment with ferumoxytol corresponded to an increased mean monthly Hb level relative to baseline (0.13-0.69 g/dL) and led to an increase in the proportion of patients maintained within the target Hb range of 10 to 12 g/dL (61%-72%). Ferumoxytol was also associated with increases in TSAT and ferritin that stabilized throughout the observation period. Incidence of AEs was similar across the 3 chains; between 0.07% and 1.77% of all patients treated at each chain experienced an AE associated with ferumoxytol administration. SAEs were reported in 0.2% of patients. The most common AEs reported (≥6 patients) were nausea (0.37% of patients), pruritus (0.29%), vomiting (0.25%), hypotension (0.21%), and dyspnea (0.20%). Two patients (0.02%) experienced anaphylactoid reactions. The AE profile of ferumoxytol remained consistent with that reported from controlled clinical trials. Conclusions These long-term data, which include repeat dosing in a large number of DD-CKD patients with IDA in a real-world setting, confirm the effectiveness of ferumoxytol in increasing and maintaining Hb levels within the target range and with favorable assessments of long-term safety. © 2014 Elsevier HS Journals, Inc. All rights reserved.

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