Navigation Links
Rockwell Medical Announces Iron Delivery Drug SFP Meets Primary Endpoint in PRIME Clinical Study Demonstrating Statistically Significant 37% Reduction in ESA Dose
Date:2/4/2013

tered as needed to treat iron deficiency. 

Primary Endpoint

The primary objective of the study was to determine whether regular administration of SFP via dialysate reduced the requirement for ESA dose by maintaining iron balance and optimizing iron delivery.  The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period).  Baseline ESA dose was similar between SFP (9448 U/wk) and placebo (9049 U/wk). In the modified ITT population, at the end of the study, ESA dose in the SFP arm was 10557 U/wk and placebo was 13345 U/wk. After adjusting for differences in baseline hemoglobin, the SFP arm required 37.1% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.034). The ESA sparing effect from SFP was observed without an increase in serum ferritin or transferrin saturation.  A total of 32 patients received rescue IV iron, 20 in placebo and 12 in SFP. Further analysis of the complete data set is ongoing and the Company plans to submit PRIME data results for presentation at a major medical meeting later in 2013.

Dr. Raymond Pratt , Chief Medical Officer of Rockwell Medical stated, "We are very excited about the results of this well-run study.  The 11 microgram/dL SFP dose delivered sufficient iron without increasing iron stores while greatly reducing ESA dose. The safety profile of SFP was similar to placebo and was well tolerated.  In this study, a 37% higher ESA dose was needed in the placebo arm to maintain hemoglobin compared to the SFP arm, but in the Phase 3 CRUISE efficacy studies the ESA dose is kept constant, unable to be titrated, over the 12-month study period.  The PRIME results support our belief that SFP will demonstrate efficacy in the Phase 3 CRUISE clinical studies by maintaining hemo
'/>"/>

SOURCE Rockwell Medical
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Soligenix Announces Formation of Oral Mucositis Medical Advisory Board
2. AdvaMed Opposes Puerto Rico Medical Device Tax Increase
3. Tandem Diabetes Care Acquires Select Patents and Patent Applications from Smiths Medical
4. Cohera Medical Named Winner of 2013 Carnegie Science Award
5. InternetArray Collaborates with Health Sciences Group to Fund Medical Marijuana Social Media/Mobile Apps Development
6. TI introduces lowest-power octal, 100-MSPS ADC for medical, industrial imaging applications
7. NICB Report On Durable Medical Equipment Fraud
8. Solta Medical to Acquire Sound Surgical Technologies
9. NSF International Acquires the INASSA Group LLC, a Peruvian Leader in Analytical Testing, Certification, Inspection and Training for the Seafood/Fishing, Food and Pharmaceutical/Medical Industries
10. New Pre-Clinical and Clinical Data on GeNO LLCs Nitric Oxide Delivery Systems to Be Presented at 2013 American College of Cardiology and American Thoracic Society Medical Meetings
11. Aethlon Medical Discloses CEO Interview
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... Germany und LONDON ... , Ziel der Zusammenarbeit sind ... genomischer Daten aus Plasmaproben zur Steuerung von Therapien ... werden kann  Neuer Bluttest basiert auf ... und soll auf Rotor-Gene Q, einer Automationsplattform der ...
(Date:7/28/2014)... 2014 OmPrompt today announces ... help it meet the global demand for customer ... logistics. Albion joins Shackleton Ventures.      ... the past 18 months OmPrompt has underpinned accelerated ... team and its operations. The new funding will ...
(Date:7/25/2014)... N.C. , July 25, 2014  In today,s ... is costly and challenging - as is managing a ... Is it possible - or even preferable ... If so, where can you combine resources and activities, ... These are just a few of ...
Breaking Medicine Technology:QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 2QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 3QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 4QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 5QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 6QIAGEN und AstraZeneca entwickeln Begleittest auf Basis von Flüssigbiopsien zur erweiterten Bestimmung von EGFR-Mutationen bei Lungenkrebspatienten 7OmPrompt Funded for Customer Automation Management Market Expansion 2Using Promotional Efficiency to Support Multiple Products and Indications in the Pharmaceutical Marketplace 2
... April 11, 2011 iCyt Mission Technology, Inc. (iCyt), ... announced the introduction of its new line of 405nm-excited ... Violet™ 421 products are part of the first commercial ... "This exciting new class of fluorescent probes will ...
... 11, 2011 Leading-edge Clinical Pharmacology and Cardiac ... announces the addition of Aziz Karim, BPharm, PhD, ... and advisor to Spaulding,s Clinical Pharmacology/Pharmacokinetic department.   ... the principles of Clinical Pharmacology and rational drug ...
Cached Medicine Technology:iCyt Unveils Exciting New Flow Cytometry Reagents Utilizing Innovative Fluorochrome Technology 2Spaulding Clinical Welcomes Dr. Aziz Karim, Clinical Pharmacokinetic Consultant 2
(Date:7/28/2014)... Amy Norton HealthDay ... Tonsillectomies are commonly done to relieve sleep apnea in children, ... kids, weight gain -- especially if they,re already overweight. ... risk factor for a range of health problems -- including, ... kids who need it. Instead, they said, doctors and ...
(Date:7/28/2014)... Lourdes Health System has partnered with ... wait times for veterans needing medical care. , Lourdes ... state—and the only one in Camden, Burlington and Gloucester ... program (PC3). PC3 gives veterans access to specialty care ... services due to lack of available specialists, long wait ...
(Date:7/28/2014)... 2014 The American Society ... professionals engaged in the field of organ transplantation, ... and Immunology Research Network (TIRN), a professional ... As modern organ transplantation continues to diversify, AST ... provide more opportunities for physicians, scientists and researchers ...
(Date:7/28/2014)... July 28, 2014 With California in ... is welcome news that a fire blanket ... protection is under development by SunSeeker Enterprises, Inc. The ... protect spacecraft from the extreme heat of re-entry into ... firefighters and homes. , “Our firefighters routinely lay their ...
(Date:7/28/2014)... Boston University School of Medicine (BUSM) report variants in ... of developing Alzheimer,s disease (AD). The discovery of this ... options that target PLXNA4 specifically. These findings appear in ... the most frequent age-related dementia affecting 5.4 million Americans ... and more than 40 percent of people age 85 ...
Breaking Medicine News(10 mins):Health News:Tonsillectomy for Sleep Apnea May Trigger Weight Gain 2Health News:Tonsillectomy for Sleep Apnea May Trigger Weight Gain 3Health News:Lourdes Expands Military Partnership with Veterans 2Health News:Lourdes Expands Military Partnership with Veterans 3Health News:American Society of Transplantation (AST) Launches Transplantation and Immunology Research Network (TIRN); Aims to Expand Research Collaboration & Funding 2Health News:American Society of Transplantation (AST) Launches Transplantation and Immunology Research Network (TIRN); Aims to Expand Research Collaboration & Funding 3Health News:Revolutionary Fire Blanket Offers Over 200 Percent More Fire Protection to Firefighters and Homes 2Health News:Researchers identify potential biomarker for AD 2
... throat strictures, cancer, group warns , FRIDAY, Aug. 31 ... heartburn once a month and more than 15 million ... of Gastroenterology. , Heartburn occurs when stomach contents ... tube that connects the mouth and the stomach. , ...
... to Help Ensure Success, ANAHEIM, Calif., Aug. 31 ... coach Tim Borland,will run a full marathon each day ... to a deadly children,s disease. His "A-T CureTour" -- ... take him,across the country, ending on Nov. 4 with ...
... MTD ) today announced the webcast of its,presentation ... on Friday, September 7, 2007, at 9:10 a.m. Eastern ... the investor relations page on the,Company,s Web site at ... be,available for seven days. METTLER TOLEDO is a ...
... Kan., Aug. 31 Juergen Richt, lead,scientist with ... and an adjunct professor at Iowa State University, ... Distinguished Professor. Richt,s appointment begins in April ... the College of Veterinary,Medicine, is the most prestigious ...
... Inc. (Nasdaq: AMCS ),a leader in radiology and medical image ... investors at the,Thomas Weisel Partners Healthcare Conference 2007 being held in ... -- Thursday, September 6, 2007 ... at 8:35 a.m. (Eastern Time), ...
... shows blocking 2 proteins could mean less invasive treatment ... -- The swelling that normally occurs when a joint ... researchers say. , Publishing in the September issue of ... two immune system proteins -- interleuken-1 and tumor necrosis ...
Cached Medicine News:Health News:Heartburn Can Be a Sign of Serious Disease 2Health News:Ultra-Runner to Run 63 Marathons in 63 Days for Children with Incurable Disease 2Health News:Ultra-Runner to Run 63 Marathons in 63 Days for Children with Incurable Disease 3Health News:Ultra-Runner to Run 63 Marathons in 63 Days for Children with Incurable Disease 4Health News:Expert on Emerging Infectious Zoonotic Diseases Joining K-State as a Regents Distinguished Professor 2Health News:Expert on Emerging Infectious Zoonotic Diseases Joining K-State as a Regents Distinguished Professor 3Health News:AMICAS to Present at Thomas Weisel Partners Healthcare Conference 2007 2Health News:Swelling After Knee Injury May Hinder Healing 2
... Pectoralis Implants come in three styles. ... is by far the most popular style. ... and are packaged and sold individually, not ... that they are each made for a ...
... In vivo results may be affected by the ... scar tissue can impact the desired augment-ation 1 ... from patient to patient. Implant dimensions can be ... surgical scissors. All dimensions in centimeters. This device ...
... in the IQmark family elevates your ECG and ... portability, cost-savings and efficient patient care. The IQmark ... the office, clinics and medical centers as well ... used in conjunction with the IQmark Digital ECG ...
24-hour full disclosure , Input range: 5mV , Analog bandwidth: 0.05 to 100Hz (3dB) , Common mode rejection ratio: 60dB , Dimensions: 4.46in. x 2.75in. x 1.02in. (113mm x 70mm x 26mm) , We...
Medicine Products: