Navigation Links
Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks
Date:10/19/2007

y assigned to either of the MIRCERA arms or to continue epoetin alfa or beta at their current dose and administration interval. Patients randomized to MIRCERA received a starting dose based on the previous weekly dose of epoetin.

In contrast to previous studies in which dialysis patients were converted from IV epoetin using sequential increases in dosing intervals, most patients in MAXIMA were converted directly from a predominantly three-times-a-week regimen of epoetin (87 percent of patients) to IV MIRCERA administered once every two weeks or once every four weeks.

MAXIMA Study Findings

The MAXIMA results showed:

-- Minute changes in Hb levels throughout the duration of the study (mean

changes from the baseline to the evaluation periods were -0.71, -0.25,

and -0.75 g/L in the MIRCERA once every two weeks; MIRCERA once every

four weeks and epoetin groups, respectively), illustrating that the

primary efficacy parameter (mean change in Hb level between baseline

and evaluation periods) was met.

-- For the secondary analysis, the proportion of patients maintaining a

mean Hb within plus or minus 10 g/L of baseline was 68 percent, 68

percent, and 67 percent in the MIRCERA once every two weeks and MIRCERA

once every four weeks and epoetin groups, respectively.

-- The most common serious adverse events in the three groups were sepsis,

pneumonia and arteriograft thrombosis. A similar incidence of adverse

events occurred across all treatment arms with the most frequent

adverse events mild to moderate and had a distribution typical for this

patient population.

About MIRCERA

The clinical program for MIRCERA consisted of 10 global studies involving more than 2,700 patients from 29 countries. The Phase III program for MIRCERA included two correction studies and four maintenance studies exploring intravenous (IV) and subcuta
'/>"/>

SOURCE Roche
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
2. Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial
3. Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkins Lymphoma
4. Accentia Biopharmaceuticals Announces Favorable Interim Blinded Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial for Chronic Sinusitis
5. Novagali Pharma Presents at AACO the Results of its Pivotal Phase III Clinical Trial of Vekacia in Children Suffering From Vernal Keratoconjunctivitis
6. Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial
7. Javelin Pharmaceuticals Announces Successful Pivotal Phase 3 Trial Data
8. Organons Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial as Compared to Neostigmine
9. Organons Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial Compared to Neostigmine
10. Pivotal Phase III Trial Showed Promacta (eltrombopag olamine) Raised Platelet Counts and Reduced Bleeding in Patients With Chronic ITP
11. Updated Overall Survival Data From Pivotal Herceptin Adjuvant Studies in HER2-Positive Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2015)... April 24, 2015 Boston Scientific Corporation (NYSE: ... 40 th Annual Healthcare Conference on May 6 in ... , executive vice president and chief financial officer, and ... a 35-minute question and answer session regarding the company with ... A live webcast of the presentation and question and answer ...
(Date:4/24/2015)... , April 24, 2015 The National ... of the National Institutes of Health [NIH])  provided ... research projects for the development of diagnostic tests ... HAI outbreaks at U.S. health facilities , the ... into rapid, multiplexed and effective tests using alternative ...
(Date:4/24/2015)... , April 24, 2015  Elekta has CE marked ... treatment planning system , enabling European clinics to deliver ... treatment techniques including advanced 3D planning, IMRT, VMAT and ... Monaco ® ... improved workflow efficiency. Advancements in 3D planning as well ...
Breaking Medicine Technology:Boston Scientific To Participate In The Deutsche Bank 40th Annual Healthcare Conference 2Kalorama: NIAID Rewards HAI Innovators with Grants 2Kalorama: NIAID Rewards HAI Innovators with Grants 3Kalorama: NIAID Rewards HAI Innovators with Grants 4Elekta CE marks for Monaco v5.10 treatment planning system 2
... Phase III monotherapy study shows ACTEMRA is first and only biologic ... ... treatment -, PARIS, ... rheumatoid arthritis (RA) -- despite treatment with,current therapies -- achieved significant ...
... NicOx S.A. (Euronext Paris: COX) today announced an ... 301 phase 3 study, showing a,statistically significant difference ... change from baseline in systolic and diastolic blood,pressure ... 4 comparisons). Commonly used,Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such ...
Cached Medicine Technology:ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 2ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 3ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 4ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 5ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 6ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies 7NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR 2NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR 3NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR 4
(Date:4/25/2015)... April 26, 2015 The National ... , a national endeavor to prepare nurses to provide ... a great success, according to a new report by ... original funding partners. , The project began in ... (CCP), under the direction of Elaine Tagliareni, EdD, RN, ...
(Date:4/25/2015)... The Hon. Ellen Tauscher, Independent Chair of ... statement following the deadly earthquake in Nepal: , "Today ... the deaths of more than 1,000 people. The ... Bangladesh, India and other parts of South Asia. ... people of Nepal and the families of the victims. ...
(Date:4/25/2015)... 2015 By definition, a CIO’s responsibility is ... enterprise relying on their judgement and expertise to keep digital ... to an article published in National Mortgage News on ... doing a disservice to their responsibilities by focusing too heavily ... are crossed when it comes to company policy and industry ...
(Date:4/25/2015)... Parker and Sons projects growth in 2015. ... in Arizona alongside the growing economy. As a result, Parker ... April to help account for the rising need for heating, ... is something we are enthusiastic about. It means growth for ... at Parker and Sons. , Indeed, Parker and Sons has ...
(Date:4/25/2015)... For thirteen years, the Twin Cities DI ... event in the nation! This year, on May 5th, 2015, ... to take DI Day on the road by supporting the ... ChFC, RHU, DIA, CLTC, Chief Executive Officer at Secura Consultants ... the change by stating, "The first Twin Cities DI Day ...
Breaking Medicine News(10 mins):Health News:Hartford Foundation Report Details Success of NLN's Advancing Care Excellence for Seniors (ACE.S) Program 2Health News:Hartford Foundation Report Details Success of NLN's Advancing Care Excellence for Seniors (ACE.S) Program 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 2Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 3Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 4Health News:An Outsider’s Perspective on Cyber Security Can Only Benefit CIOs 5Health News:Parker and Sons Plans to Expand in 2015 2Health News:Secura Consultants Takes DI Day On The Road 2
... NEW YORK, June 10 Tongji Healthcare, Inc.,(OTC Bulletin ... in China, reports that its hospital are enjoying an,influx ... province., Due to its status as a private ... Beijing that he has suggested the government would,pick up ...
... As nearly 80 percent of adults,experience back pain ... Carolina this month will launch a free, back care ... of the most common medical problems and affects eight,out ... In South Carolina, back,disorders were among the top causes ...
... of patients with testicular cancer are cured nowadays, but ... survivors, the medical profession and national governments, a cancer ... on Teenage and Young Adult Cancer Medicine, which is ... and 10). , Dr Craig Nichols, director of program ...
... The Endocrine Society will present Ronald S. ... Biomedical Research Institute at Harbor-UCLA Medical Center (LA ... annual convention June 15-18 in San Francisco. , ... members representing the full range of disciplines associated ...
... But their tech savvy helps them use online programs ... June 10 (HealthDay News) -- Insomnia among U.S. combat ... seen in patients with chronic insomnia, according to University ... post-deployment adjustment disorders to 14 insomnia patients and 14 ...
... Mylan Inc. (NYSE: MYL ),announced today ... agreement with,NATCO Pharma Ltd. (NATCO) for NATCO,s glatiramer ... which is used to treat,multiple sclerosis. The agreement ... and all major markets in Europe, Australia, New,Zealand, ...
Cached Medicine News:Health News:Tongji Healthcare Services Reports Influx of Patients 2Health News:BlueChoice HealthPlan to Launch Back Care Program 2Health News:Experts highlight gaps in knowledge on caring for survivors of teenage and young adult cancers 2Health News:Experts highlight gaps in knowledge on caring for survivors of teenage and young adult cancers 3Health News:Experts highlight gaps in knowledge on caring for survivors of teenage and young adult cancers 4Health News:LA BioMed investigator wins Distinguished Educator Award 2Health News:Combat Vets Display Severe Sleep Disorders 2Health News:Mylan Inc., NATCO Pharma Ltd. To Collaborate on Worldwide Marketing and Distribution of Generic Copaxone(R) 2
The Guidant Fineline EZ leads with protective capsule are bipolar endocardial and designed for permanent implantation with pulse generators for cardiac pacing....
Tendril DX active-fixation leads allows for lower thresholds initially and during the lead maturation phase....
... The Model 6491 unipolar ... designed for temporary atrial and ... and after cardiac surgery. This ... downsized, making it the ideal ...
... Guidant Flextend lead is ... lead with an extendable/retractable ... helix design offers various ... permanent implantation in the ...
Medicine Products: