Navigation Links
Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
Date:2/11/2008

BOUT THE SULONEX (sulodexide oral gelcap) PHASE 3 and PHASE 4 CLINICAL PROGRAM

Sulodexide is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food and Drug Administration. These trials are being conducted by the Collaborative Study Group, the world's largest standing renal clinical trials group.

The clinical plan to support an NDA approval for sulodexide under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in subjects with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) substantial recruitment into our Phase 4 confirmatory study that will measure clinical outcomes in subjects with overt nephropathy, or macroalbuminuria.

The Phase 3 clinical program is a multi-center, randomized, double-blind, placebo-controlled study, comparing 200 mg daily of sulodexide versus placebo, with a 1:1 randomization between the two arms. The objective of this study is to evaluate the safety and efficacy of sulodexide in subjects with type 2 diabetes and persistent microalbuminuria, or diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). The study is designed for subjects to be on drug for six months, followed by two months of evaluation off-drug.

During the drug and off-drug evaluation period, all subjects in the study population are expected to continue to receive maximum approved or tolerated doses of ACEis or ARBs. Subjects who were not already on maximum approved or tolerated doses of ACEis or ARBs for 120 days were required to go into a run- in period prior to randomization of up to 120 days. This run-in period was designed to stabilize blood pressure and to confirm persistent microalbu
'/>"/>

SOURCE Keryx Biopharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
2. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
3. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
4. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
5. XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International Scientific Conference on Viral Hepatitis
6. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
7. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
8. Morria Biopharmaceuticals Plc Initiates Phase I Clinical Study of MRX-4 in Allergic Rhinitis
9. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... Oct. 1, 2014 NeuroCall, Inc., ("NeuroCall") announced ... its Telestroke and Teleneurology services. Dr. Ricardo Garcia-Rivera ... "We are extremely proud that our quality of service ... continue to provide lifesaving support and continuity of care ... throughout the United States ." ...
(Date:10/1/2014)... , Oct. 1, 2014 Quantum Materials ... volume production of photoactive quantum dots for use ... While offering numerous advantages for solar power generation, ... quantities of quantum dots with which to develop ... them from commercial utilization and acceptance. The company ...
(Date:10/1/2014)... 1, 2014 Sophia Genetics, ... domaine de l,analyse des données issues du SNG ... de diagnostic in vitro (IVD) du gène CFTR ... la mucoviscidose dans un seul essai SGN. La ... les types de variantes par l,intermédiaire d,un seul ...
Breaking Medicine Technology:NeuroCall Awarded Joint Commission Accreditation 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 2Quantum Materials Scaling Up Photoactive Quantum Dot Production for Solar Power Generation 3Sophia Genetics lance une analyse complète du gène CFTR dans un essai clinique SGN 2Sophia Genetics lance une analyse complète du gène CFTR dans un essai clinique SGN 3
(Date:10/1/2014)... 2014) Despite a policy focus on expanding ... this vulnerable population continues to have significant dental ... Journal of the American Dental Association , researchers ... University School of Dental Medicine report on the ... oral care provided by caregivers to adults with ...
(Date:10/1/2014)... Familylifeinsurancequotes.org has released a new blog ... citizens. , Senior citizens can qualify for affordable ... to seniors who are over 50 years old. Some ... a medical examination. , Term life insurance with a ... can qualify. Having life insurance during retirement is important ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 Insuranceragents.info ... find a good life insurance plan for vulnerable family ... for vulnerable family members. Providers in the family should ... will cause financial hardships for the rest of the ... of policies. Families can benefit more from temporary coverage ...
(Date:10/1/2014)... Lifeinsurance-policy.com has released a new blog ... prices for smokers. , Smoking will always have a ... is the best method to find affordable coverage. Insurance ... need coverage. , Whole life insurance premiums will ... Since the coverage is permanent, the initial rates ...
(Date:10/1/2014)... Phoseon Technology, the pioneer in developing ... the business worldwide. This rapid growth includes increased hiring ... manufacturing efforts. The company has experienced average annual growth ... expects this growth to continue in the future as ... adoption. , “We are very pleased that ...
Breaking Medicine News(10 mins):Health News:To improve oral health of adults with developmental disabilities, support caregivers 2Health News:To improve oral health of adults with developmental disabilities, support caregivers 3Health News:Affordable Term Life Insurance - Senior Citizens Can Qualify for Coverage! 2Health News:Life Insurance for Families - Clients Can Compare Affordable Rates Online! 2Health News:Affordable Whole Life Insurance Premiums for Smokers! 2Health News:Phoseon Technology Continues to Drive Growth Worldwide 2
... too, DENVER, Jan. 30 With the high ... want to heed advice,from two of the country,s leading ... speeches and pep rallies leading up to February 5, ... trail such as cheering,supporters, political pundits, and media analysts, ...
... Regional Healthcare System has,selected TransUnion,s Healthcare Revenue Cycle ... streamline administration of its charity,care policy., The ... hospital,system with campuses in Elyria, Amherst, and Avon, ... has served the needs of Lorain County and,greater ...
... 30 Sports and,nutritional product manufacturer, Natural Nutrition ... today a forward split of,its common stock. Each ... for every four shares owned as of the ... of record as of February 8, 2008, will ...
... stimulation (DBS) surgery, which is used to treat Parkinsons ... for its potential to treat a variety of conditions. ... to treat cluster headaches and aggressiveness in humans, and ... new study found that hypothalamic DBS performed in the ...
... Control No Matter Where,You Live, WASHINGTON, Jan. 30 ... the #1 Asthma Capital(TM) -- the most,challenging place to live ... Foundation of America (AAFA)., Since 2004, AAFA has conducted ... in America and to rank,them based on the quality of ...
... Jan. 29 John Josef Molenda has joined ... in the Firm,s Intellectual Property,and Appellate and Supreme ... an associate at Frommer Lawrence & Haug,LLP, where ... patent litigation. Dr. Molenda, who has a Ph.D. ...
Cached Medicine News:Health News:Candidates Risk Harming Voice in Final Week to Super Tuesday 2Health News:EMH Regional Medical Center Selects TransUnion's Healthcare Revenue Cycle Platform to Help Reduce Its Bad Debt 2Health News:EMH Regional Medical Center Selects TransUnion's Healthcare Revenue Cycle Platform to Help Reduce Its Bad Debt 3Health News:Natural Nutrition Announces Forward Split of Common Stock 2Health News:Deep brain stimulation may improve memory 2Health News:Asthma Foundation Announces 2008 Asthma Capitals, Knoxville on Top Again 2Health News:Asthma Foundation Announces 2008 Asthma Capitals, Knoxville on Top Again 3
The clarity and performance of glass with shatterproof safety of plastic....
Accurate and easy hematocrits in two minutes. Choose glass or easy to read SafeCrit plastic tubes, plain or heparinized. These tubes feature rapid capillary action and have a two-year shelf life. For...
... In the Innova™ 4100, the ... X-ray system for angiographic imaging, ... piece, non tiled Digital Detector ... reliably provide high resolution imaging ...
... is a bench-top fully automated random ... host of features usually only seen ... has the capacity to perform up ... ISEs, and offers primary tube sampling, ...
Medicine Products: