ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease Receiving Chronic Hemodialysis

This study is currently recruiting participants.
Verified by Rockwell Medical Technologies, Inc., August 2008

Sponsored by: Rockwell Medical Technologies, Inc.
Information provided by: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00548249
  Purpose

The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.


Condition Intervention Phase
End-Stage Renal Disease
Drug: soluble ferric pyrophosphate
Phase II

MedlinePlus related topics:   Dialysis    Kidney Failure   

ChemIDplus related topics:   Ferric pyrophosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:   A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.

Further study details as provided by Rockwell Medical Technologies, Inc.:

Estimated Enrollment:   100
Study Start Date:   September 2007
Estimated Study Completion Date:   May 2009
Estimated Primary Completion Date:   May 2009 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: soluble ferric pyrophosphate
    0, 5, 10, 12, 15 and possibly 20mcg iron/dl of dialysate
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  1. Adult subject ≥18 years of age undergoing chronic hemodialysis for end-stage renal disease (ESRD) three times a week
  2. Hemoglobin values on two successive screening/baseline measures immediately prior to the start of the study of 10.1 to 11.5 g/dL
  3. TSAT values that average 20% or more, but not exceeding 35% prior to dialysis measured during the screening period
  4. Ferritin values that average 200 to 800 μg/L measured during the screening period
  5. Subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
  6. Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal Investigator

Exclusion Criteria:

  1. Hemoglobin values on two successive baseline/screening measurements that average ≥11.6g/dL
  2. Subject with a current malignancy involving sites other than skin
  3. Subject with a history of drug or alcohol abuse within the last six months
  4. Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease,life expectancy of less than a year)
  5. Subject who the Principal Investigator considers will be placed at increased risk by the study procedures
  6. Subject requiring hemodialysis more than 3 times per week on a regular basis.
  7. Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study.
  8. Subject who is pregnant
  9. Subject considered incompetent to give an informed consent
  10. Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening
  11. Subject with known HIV infection (If this is not known, no HIV testing will be performed.)
  12. Subject with cirrhosis of the liver based on histological criteria or clinical criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy). Subject with hepatitis C, in the absence of cirrhosis, is not excluded from participation in the study if ALT and AST levels are below 2 times the upper limit of normal consistently during the 2 months preceding enrollment
  13. Subject with active tuberculosis, fungal, viral, or parasitic infections
  14. Subject with active bacterial infections requiring antibiotic therapy
  15. Subject with a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval ≥450 milliseconds (ms)
  16. Subject with a history of additional risk factors for Torsades de Pointe ( e.g. heart failure,hypokalemia, family history of Long QT Syndrome)
  17. Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I)
  18. Subject receiving more than 30,000 units or 60 micrograms of erythropoietin (Epogen®,Procrit®, Aranesp®) per week
  19. Subject has participated in another clinical trial within 30 days of signing Informed Consent
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548249

Contacts
Contact: Carrie D Guss, RD MSBA     248-960-9009     cguss@rockwellmed.com    

Locations
United States, Georgia
Investigative Site     Recruiting
      Augusta, Georgia, United States, 30901
      Principal Investigator: Investigative Site            
United States, Kentucky
Investigative Site     Recruiting
      Louisville, Kentucky, United States, 40202-1718
      Principal Investigator: Investigative Site            
United States, Michigan
Investigative Site     Recruiting
      Detroit, Michigan, United States, 48202
United States, Ohio
Investigative Site     Recruiting
      Canton, Ohio, United States, 44718
      Principal Investigator: Investigative Site            
United States, Pennsylvania
Investigative Site     Recruiting
      Hershey, Pennsylvania, United States, 17033
      Principal Investigator: Investigative Site            

Sponsors and Collaborators
Rockwell Medical Technologies, Inc.

Investigators
Investigator:     Please Call for Information    
  More Information


Responsible Party:   Rockwell Medical Technologies, Inc. ( Robert Chioini, President and CEO )
Study ID Numbers:   RMTI-SFP-2
First Received:   October 19, 2007
Last Updated:   August 21, 2008
ClinicalTrials.gov Identifier:   NCT00548249
Health Authority:   United States: Food and Drug Administration

Keywords provided by Rockwell Medical Technologies, Inc.:
Subjects with ESRD receiving chronic Hemodialysis  

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Iron
Kidney Failure

Additional relevant MeSH terms:
Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




Links to all studies - primarily for crawlers