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Sponsored by: |
Rockwell Medical Technologies, Inc. |
Information provided by: | Rockwell Medical Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00548249 |
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 |
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. |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carrie D Guss, RD MSBA | 248-960-9009 | cguss@rockwellmed.com |
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 |
Rockwell Medical Technologies, Inc. |
Investigator: | Please Call for 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 |
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